Clinical Research Registry

No Registry Status Registry
  Complete   Bioequivalence study of Aspirin 100 mg enteric coated tablet, Miniaspi manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Aspirin 100 enteric coated tablet, Cardio Aspirin made by Bayer AG, Leverkusen - Germany for Bayer Consumer Care AG, Switserland; Imported by PT Bayer Indonesia, Depok - Indonesia 
Interventions:  
INA-DOBP5OS  Complete   THE EFFECTIVNESS P6 ACUPRESSURE TO OVERCOME NAUSEA AND VOMITING DURING EARLY PREGNANCY 
Interventions: The intervention group (pregnant women with NVP + dual P6 acupressure P6 and the control group (pregnant women with NVP) were in different study locations. In this design, the intervention group underwent P6 acupressure on both arms, one arm had used manual massage and another arm had used acupressure band. On the other hand, the comparison group experiences NVP without the dual P6 acupressure and without pharmacological intervention 
INA-T6T7G57  Complete   DUAL METHOD P6 ACUPRESSURE TO OVERCOME NAUSEA AND VOMITING DURING EARLY PREGNANCY 
Interventions: Non-invasive intervention, the Dual methode P6 acupressure using pressure and the use of band acupressure in the P6 area of the arm. 
INA-CDM38T8  Complete   Bioequivalence Study of Fungasol (Ketoconazole 200 mg) Tablet Produced by PT Guardian Pharmatama in Comparison with Ketoconazole 200 mg Tablet Manufactured by Taro Pharmaceuticals Industries Ltd., Haifa Bay, Israel, Distributed by Taro Pharmaceuticals USA, Inc. 
Interventions: Fungasol 200 mg tablet, manufactured by PT Guardian Pharmatama 
INA-GFMDTRZ  Complete   Bioequivalence study of divalproex sodium 500 mg extended-release tablet produced by PT Ikapharmindo Putramas Tbk. in comparison with the comparator drug (Depakote® 500 mg Extended-Release Tablet of PT Abbott Indonesia, Indonesia) 
Interventions: The participating subjects were given orally one test drug (divalproex sodium 500 mg extended-release tablet produced by PT Ikapharmindo Putramas Tbk.) after an overnight fast of at least 8 hours with approximately 200 mL of water at ambient temperature. 
INA-A9Q1G1X  Complete   Bioequivalence Study of Amlodipine 10 mg caplet, Licodipin-10 manufactured by PT Berlico Mulia Farma in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions:  
INA-0599RT2  Complete   Uji Bioekivalensi NORGESTIN® SCT (Levonorgestrel 0,15 mg dan Etinilestradiol 0,03 mg) Produksi PT Sanbe Farma dibandingkan terhadap MICROGYNON® SCT (Levonorgestrel 0,15 mg dan Etinilestradiol 0,03 mg) Produksi Schering Do Brasil Quimica E Farmaceutica LTDA., Brasil pada Subjek Sehat 
Interventions: Obat (Norgestin/Microgynon yang mengandung Levonorgestrel 0.15 mg dan Etinilestradiol 0.03 mg) diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air pada suhu ruang. 
INA-98KL19S  Complete   Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories (Helixim® Dry Syrup) in comparison with the comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one of test drug (cefixime 100 mg/5 mL dry syrup produced by PT IFARS Pharmaceutical Laboratories) or one of comparator drug (Cefspan® 100mg/5mL Dry Syrup, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan). 
INA-ODT4OY2  Initial   Efektivitas model optimalisasi tumbuh kembang bayi prematur berbasis buku KIA terhadap self efficacy ibu, pertumbuhan dan perkembangan bayi prematur 
Interventions: The intervention phase begins with randomization. Researchers will assign participants to the intervention group or control group according to the randomization results. Researchers will measure the mother's self-efficacy before receiving intervention. The intervention will take place in the hospital and at the participant's home. The intervention at the hospital took the form of an explanation given by the nurse to the mother of a premature baby about caring for a premature baby using the book MCH for Small Babies. Explanation of material on caring for premature babies will be divided into three sessions. Each session takes place on each mother's visit on a different day. After receiving the explanation, mothers will be given the opportunity to ask questions and practice the skills that have been explained. In the third session the researcher will again measure the mother's self-efficacy using the Indonesian version of the PMP-SE. After completing the third session, data collection will continue at the participant's home when the baby is allowed to go home. The hospital nurse will inform the premature baby's discharge plan via WAG social media. Community nurses who are members of the WAG will respond to information by planning visits as a post-hospitalization intervention. This post-hospitalization intervention will last four sessions, namely the first visit in the first week of discharge, the 2nd visit in the third week of discharge, the 3rd visit in the seventh week of discharge and the final 4th visit in the twelfth week of the premature baby's discharge. At each visit, researchers will provide education to mothers about caring for premature babies at home. Researchers will measure the mother's self-efficacy, baby's weight, baby's body length and baby's head circumference. The measurement results will be documented in the research logbook and the MCH book for Small Babies. On the fourth visit, the researcher will convey that the data collection process has been completed so that the mother's participation has been completed 
INA-P3H511H  Complete   Bioequivalence Study of Captopril 25 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Captopril 50 mg Tablet Produced by PT Dexa Medica, Indonesia 
Interventions: Captopril 25 mg Tablet (2 x 25 mg) Produced by PT Trifa Raya Laboratories 
INA-C2P99NH  Complete   Uji Bioekivalensi Irbeten® 300 FCT (Irbesartan 300 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Aprovel® FCT (Irbesartan 300 mg) Produksi Sanofi Winthrop Industrie, Perancis Diimpor oleh PT Aventis Pharma, Indonesia pada Subjek Sehat 
Interventions: Penelitian bioekivalensi dosis tunggal, randomized, double blind, menyilang dalam waktu 2 periode, dan dengan kondisi puasa. Obat uji (Irbeten® 300 FCT) dan obat komparator (Aprovel® FCT) diberikan secara oral, dalam keadaan puasa dan dalam posisi duduk, dengan 220 mL air pada suhu ruang. (Abstrak pada Laporan Uji Bioekivalensi Irbeten 300 FCT) 
INA-18WNDYZ  Complete   Bioequivalence Study of Amlodipine Besylate Tablet 10 mg manufactured by PT Tempo Scan Pacific Tbk. in comparison with Amlodipine Besylate, Norvask® Tablet 10 mg manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine Besylate 10 mg tablet manufactured by PT Tempo Scan Pacific 
INA-03MN8ZG  Complete   Bioequivalence study of Koniflam (Meloxicam 15 mg) tablet produced by PT Konimex in Comparison with Mobic® (Meloxicam 7.5 mg) tablet manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany. 
Interventions:  
INA-GBE4Z3D  Complete   Bioequivalence study of Gluditin (Sitagliptin 100 mg) film coated tablet produced by PT Konimex in Comparison with Januvia (Sitagliptin 100 mg) tablet manufactured by Merck Sharp & Dohme Ltd., England, imported by PT Merck Sharp Dohme Pharma Tbk., Indonesia. 
Interventions:  
INA-8GMN58A  Complete   Bioequivalence Study of Piroxicam capsule 20 mg manufactured by PT. Itrasal in comparison with Feldene capsule 20 mg manufactured by Pfizer Pharmaceuticals LLC Ireland 
Interventions: Piroxicam capsule 20 mg manufactured by PT. Itrasal 
INA-4H6FAA3  Complete   Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT Pharos Indonesia (Profibrat) in Comparison with the Innovator's Capsules (Lipanthyl), Manufactured by Recipharm Fontaine, France, Imported and Repacked by PT Combiphar, Bandung, Indonesia 
Interventions: Single dose of 200 mg Fenofibrate Capsules (Profibrat®), Manufactured by PT Pharos Indonesia 
INA-ADD0Q0F  Complete   Bioequivalence Study of 300 mg Gabapentin Capsules, Manufactured by PT Mudita Karuna for PT Pharma Laboratories (Pharmaneuro®) in Comparison with the Innovator's Capsules (Neurontin®), Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Packed and Released by Pfizer manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Germany, Imported by PT Pfizer Indonesia, Jakarta-Indonesia 
Interventions: Single dose of 300 mg Gabapentin Capsules (Pharmaneuro®), Manufactured by PT Mudita Karuna for PT Pharma Laboratories 
INA-Y0WKZE6  Complete   Bioequivalence Study of 100 mg Sitagliptin Tablets, Manufactured by PT Lapi Laboratories (Glutin®) in Comparison with The Innovator's Tablets (Januvia®) Manufactured by Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington, Northumberland NE23 3JU, England, Registered and Packaged by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur 
Interventions: Single dose of 100 mg Sitagliptin Tablets (Glutin®), Manufactured by PT Lapi Laboratories 
INA-RQBA8G2  Complete   Bioequivalence Study Of Irbesartan 300 Mg Film-Coated Tablets Manufactured By Pt Kimia Farma Tbk In Comparison With Aprovel® 300 Mg Film-Coated Tablets Manufactured By Sanofi Winthrop Industrie, France, Registered By Pt Aventis Pharma, Indonesia 
Interventions: Irbesartan 300 mg film-coated tablet manufactured by PT Kimia Farma Tbk 
INA-6638254  Complete   Bioequivalence study of 90 mg Etoricoxib Tablets, Manufactured by PT Lapi Laboratories (Etoricoxib LAPI) in Compartison with the Innovator's Tablets (Arcoxia™) Manufactured by Frosst Iberica, S.A. Via Complutence, 140, Madrid, Spain, Registered and Packed by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur 
Interventions: Single dose of 90 mg Etoricoxib Tablet (Etoricoxib LAPI) manufactured by PT Lapi Laboratories 
INA-O8EX278  Complete   DEDIKASI-App, Skin diseases early case detection 
Interventions: Community members in the intervention group will be invited to utilize the DEDIKASI-app for checking themselves for common skin diseases. 
INA-PDA4BAX  Complete   Bioequivalence Study of 90 mg Etoricoxib Tablets, Manufactured by PT Lapi Laboratories (Etoricoxib LAPI) in Comparison with The Innovator's Tablets (Arcoxia™) Manufactured by Frosst Iberica, S.A. Via Complutence, 140, Madrid, Spain, Registered and Packed by PT Merck Sharp Dohme Pharma Tbk., Pandaan, Jawa Timur 
Interventions: Single dose of 90 mg Etoricoxib Tablet (Etoricoxib LAPI) manufactured by PT Lapi Laboratories 
INA-Z59S50H  Complete   DEDIKASI-app, a mobile-phone application for the early detection of skin diseases 
Interventions: Community members in the intervention group will be invited to utilize the DEDIKASI-app for checking themselves for common skin diseases. 
INA-R0CG1GR  Complete   Bioequivalence Study of Meloxin 15 mg Tablet Manufactured by PT Interbat in Comparison Movalis® 15 mg Tablet Manufactured by Rottendorf Pharma GmbH, Ostenfelder Strasse 51-61, 59320 Ennigerloh, Deutschland for Boehringer Ingelheim RCV GmbH & Co KG, Dr. Boehringer-Gasse 5-11, 1121 Wien. 
Interventions: Meloxin 15 mg tablet 
INA-OPW2DR2  Complete   Bioequivalence Study of Tamoxifen 20 mg Tablets Manufactured by PT Global Onkolab Farma in Comparison with Novaldex® 20 mg Tablets Manufactured by AstraZeneca UK Ltd., United Kingdom. 
Interventions: Tamoxifen 20 mg tablets 
INA-S8S18TO  Complete   Bioequivalence study of metformin hydrochloride 500 mg film coated tablet produced by PT Novapharin in comparison with the comparator drug (Glucophage® 500 mg Film-Coated Tablet, manufactured by PT Merck Tbk., Indonesia, under license from Merck Sante S.A.S., France) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of the test drug (metformin hydrochloride 500 mg film-coated tablet produced by PT Novapharin) or one film-coated tablet of the comparator drug (Glucophage® 500 mg Film-Coated Tablet, manufactured by PT Merck Tbk., Indonesia, under license from Merck Sante S.A.S., France) with approximately 200 mL of water at ambient temperature. 
INA-M1BAW1C  Complete   Bioequivalence study of cefixime trihydrate 200 mg capsule produced by PT Novapharin in comparison with the comparator drug (Cefspan® 100 mg Capsule produced by PT Dankos Farma, Indonesia, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co. Ltd., Osaka, Japan) 
Interventions: cefixime trihydrate 200 mg capsule produced by PT Novapharin 
INA-9EMC7TQ  Complete   Bioequivalence study of trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma in comparison with the comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) when administered under fed condition in healthy subjects 
Interventions: The participating subjects were given orally either one test drug (trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Mahakam Beta Farma) or one comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) 30 minutes after the subjects have consumed a standardized breakfast meal in the first day of each period with approximately 200 mL of water at ambient temperature. 
INA-GSQLZ2T  Complete   Bioequivalence study of Apixaban 5 mg film coated tablet produced by PT Pratapa Nirmala in Comparison with Eliquis (Apixaban 5 mg) film coated tablet manufactured by Pfizer Ireland Pharmaceuticals, Ireland, packed and released by Pfizer Manufacturing Deutschland, GmbH, Germany, imported by PT Pfizer Indonesia. 
Interventions:  
INA-P7DDYC5  Complete   Bioequivalence study of Helixim 200 mg film coated caplet (Cefixime 200 mg) manufactured by PT IFARS Pharmaceutical Laboratories in comparison Cefspan® film coated caplet (Cefixime 200 mg) manufactured by PT Dankos Farma for PT Kalbe Farma Tbk, under licensed of Otsuka Chemical Co., Ltd Japan 
Interventions: Helixim 200 mg film coated caplet (Cefixime 200 mg) manufactured by PT IFARS Pharmaceutical Laboratories 
INA-7H2XQFW  Complete   Bioequivalence study of tamsulosin 0.4 mg sustained release film coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Harnal® OCAS 0.4 mg Prolonged Release Tablet produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia) when administered under fasting condition in healthy subjects. 
Interventions:  
INA-2XNQM08  Complete   Bioequivalence Study of Rosuvastatin 20 mg Film Coated Tablets, manufactured by PT Kimia Farma Tbk in comparison with Rosuvastatin 20 mg Film Coated Tablets, Crestor® manufactured by IPR Pharmaceuticals Inc. Puerto Rico for AstraZeneca UK Limited, United Kingdom; packed and 
Interventions: Rosuvastatin Film Coated Tablet manufactured by PT Kimia Farma Tbk. 
INA-4F6QO2Z  Complete   Bioequivalence Study of 15 mg Pioglitazone & 500 mg Metformin Tablets Manufactured by PT. Dankos Farma (Pionix M 500) in Comparison with Metact® Combination Tablets LD 15/500 Manufactured by Teva Takeda Pharma Ltd., Japan 
Interventions: Pionix M 500 
INA-R0MH9CQ  Complete   Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Pratapa Nirmala in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet manufactured by PT Pratapa Nirmala 
INA-COE7WYH  Complete   UJI BIOEKIVALENSI TABLET FORMYCO® (KETOCONAZOLE 200 mg) PRODUKSI PT SANBE FARMA DIBANDINGKAN TERHADAP TABLET KETOCONAZOLE (KETOCONAZOLE 200 mg) PRODUKSI TARO PHARMACEUTICAL INDUSTRIES Ltd., ISRAEL DIDISTRIBUSIKAN OLEH TARO PHARMACEUTICALS U.S.A., Inc., AMERIKA SERIKAT PADA SUBJEK SEHAT 
Interventions: Penelitian yang dilakukan adalah penelitian bioekivalensi dosis tunggal. Penelitian dilakukan dengan desain acak, double blind, dan menyilang dalam 2 periode (two-way crossover design). Menggunakan Tablet FORMYCO® (Ketoconazole 200 Mg) produksi PT Sanbe Farma dibandingkan terhadap Tablet Ketoconazole (Ketoconazole 200 Mg) produksi Taro Pharmaceutical Industries Ltd., Israel didistribusikan oleh Taro Pharmaceuticals U.S.A., Inc., Amerika. 
INA-K3S76P6  Complete   bioequivalence study of Ketoprofen 100 mg Enteric coated tablet manufactured by PT Bernofarm in comparison with Ketoprofen 100 mg Enteric coated tablet manufactured by PT Novell Pharmaceutical Laboratories, Indonesia 
Interventions: Ketoprofen 100 mg Enteric coated tablet manufactured by PT Bernofarm 
INA-74HCGYH  Complete   Bioequivalence study of Itraconazole 100 mg capsule, Forcanox® manufactured by PT Guardian Pharmatama in comparison with Itraconazole 100 mg capsule, Sporanox® manufactured by Jansen-Cilag S.p.A, via C. Janssen, Italy; product registrant by Johnson & Johnson Pte Ltd Singapore 
Interventions: Forcanox® manufactured by PT Guardian Pharmatama - Indonesia 
INA-C4P3LNC  Complete   Bioequivalence study of meloxicam 15 mg tablet produced by PT Meprofarm in comparison with the comparator drug (Movalis® 15 mg Tablet produced by Boehringer Ingelheim Hellas Single Member S.A., Markopoulo, Greece, Under License of Boehringer Ingelheim RCV GmbH & Co, Vienna) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one of test drug (meloxicam 15 mg Tablet produced by PT Meprofarm) or one of comparator drug (Movalis® 15 mg Tablet produced by Boehringer Ingelheim Hellas Single Member S.A., Markopoulo, Greece, Under License of Boehringer Ingelheim RCV GmbH & Co, Vienna). 
INA-RM0AYFY  Complete   bioequivalence study of Clobazam 10 mg tablet, Proclozam manufactured by PT Meprofarm in comparison with Clobazam 10 mg tablet, Frisium® manufactured by PT Aventis Pharma, Indonesia 
Interventions: Clobazam 10 mg tablet, Proclozam®, manufactured by PT Meprofarm 
INA-Y1F01SL  Complete   bioequivalence study of Pyrazinamide 500 mg tablet, TB Zet manufactured by SW Pharma GmbH, Schiffweiler – Germany 
Interventions: Pyrazinamide 500 mg tablet, TB Zet®, manufactured by PT Meprofarm 
INA-NAY7PX1  Complete   Bioequivalence study of Rifampicin 100 mg/5 mL Oral Suspension produced by PT Meprofarm in comparison with the comparator drug (Rifadin® 20 mg/mL Oral Suspension produced by Sanofi S.r.l., Italy) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally 15 mL of test drug (Rifampicin 100 mg/5 mL Oral Suspension produced by PT Meprofarm) or 15 mL of comparator drug (Rifadin® 20 mg/mL Oral Suspension produced by Sanofi S.r.l., Italy). 
INA-SE4KSQ4  Complete   bioequivalence study of Alprazolam 1 mg tablets, Prazox manufactured by Pfizer Pharmaceuticals LLC, Barceloneta, Puerto Rico; packaged dan released by Pfizer Italia S.r.l., Ascoli, Italia; imported by PT Pfizer Indonesia, Indonesia 
Interventions: Alprazolam 1 mg tablets, Prazox manufactured by PT Meprofarm 
INA-NCZDPMR  Complete   Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Samquinor® 500 mg) Manufactured by PT Samco Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer Co. (Malaysia) Sdn Bhd, Malaysia 
Interventions: Samquinor® 500 mg film-coated caplets 
INA-CKAWTDE  Complete   Bioequivalence study of Amlodipine-Valsartan 5/160 mg Film Coated Tablet manufactured by PT Kimia Farma Tbk in comparison with Amlodipine-Valsartan 5/160 mg Film Coated Tablet, Exforge manufactured by Novartis Pharma AG, Switzerland; Imported by PT Novartis Indonesia 
Interventions: AMLODIPINE-VALSARTAN 5/160 MG FILM COATED TABLET MANUFACTURED BY PT KIMIA FARMA TBK 
INA-A3BD6H9  Complete   A Phase II Non-Randomized Open Label, Clinical Trial to Evaluate the Safety and Immunogenicity of SARS-COV-2 Vaccine (Vero Cell) Inactivated as A Booster Dose Protocol Number: BOOST-VC-0221 
Interventions: Sinopharm Vaccine 
INA-E9C7LPM  Complete   BCG Vaccination for TB Prevention in Adults 
Interventions: Bacillus Calmette Guerin (BCG) 
INA-SS248XA  Complete   A Randomized, Observer Blinded, Active Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years 
Interventions: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus Vaccine (Escherichia coli) 
INA-3ZP3TWY  Complete   BCG Vaccination/Revaccination for Prevention of Mycobacterium Tuberculosis Infection in Healthcare Students Entering Clinical Training: A Randomised Placebo-Controlled Proof of Principle Trial (PoP BCG Trial) 
Interventions: BCG Vaccine: 1 adult dose (0,1 ml) of vaccine is administered by intradermal injection. 
INA-F7MRQNA  Complete   A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older 
Interventions: Recombinant SARS CoV 2 fusion protein vaccine (V 01) 
INA-F7MRQNA  Complete   A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older 
Interventions: Recombinant SARS CoV 2 fusion protein vaccine (V 01) 
INA-HB8C9XD  Complete   A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older 
Interventions: Recombinant COVID-19 vaccine (Sf9 cell) 
INA-KOPKZN8  Complete   Bioequivalence Study of 10 mg Lisinopril Dihydrate Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Zestril® 10 mg Tablets Manufactured by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by the Marketing Authorization Holder AstraZeneca Pharmaceuticals (Phils.), Inc., Philippines 
Interventions: Lisinopril Dihydrate 10 mg Tablets manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Lab 
INA-G4H9QTD  Initial   Effect of an Epilepsy Education Programe On Parental Knowledge, Medication Adherence, Seizure Recurrence And Quality Of Life In Children With Epilepsy 
Interventions: Intervention Group Before 1 time of education, the patient's family was asked to fill in the respondent data questionnaire, knowledge level questionnaire, medication adherence questionnaire and quality of life questionnaire for approximately 15 minutes. Educational materials will be given directly through a laptop directly to the respondent for 10-15 minutes and 5 minutes of question and answer session. There were 3 times sending educational videos in weeks 2, 3 and 4 and whatsapp reminders to take standardised medication, week 5 evaluation by filling out questionnaires on knowledge level, medication adherence and quality of life. This series of educational programmes was documented in the PEE documentation sheet. 
INA-07C3WWP  Complete   Bioequivalence study of cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories (Helixim® 100 Capsule) in comparison with the comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories) or one comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) with approximately 200 mL of water at ambient temperature. 
INA-OMNC3D1  Initial   The effect incubator covers with dampening materials on the physiological responses and sleep patterns of premature babies 
Interventions: Intervention Group Before 1 time of education, the patient's family was asked to fill in the respondent data questionnaire, knowledge level questionnaire, medication adherence questionnaire and quality of life questionnaire for approximately 15 minutes. Educational materials will be given directly through a laptop directly to the respondent for 10-15 minutes and 5 minutes of question and answer session. There were 3 times sending educational videos in weeks 2, 3 and 4 and whatsapp reminders to take standardised medication, week 5 evaluation by filling out questionnaires on knowledge level, medication adherence and quality of life. This series of educational programmes was documented in the PEE documentation sheet. 
INA-TFKL3Z8  Initial   The Effect Of Six Hour Kangaroo Method Care On Weight Increase In Premature Babies And The Emotional Bonding Of Mother And Baby 
Interventions: The mother carried out kangaroo mother care for six hours, starting time according to the agreement between the mother and the researcher. Mothers are allowed to change their sitting position to lying down or walk around while carrying out kangaroo mother care treatment for six hours. Mothers can also take it off when they want to go to the bathroom. 
INA-HPZ7L6C  Complete   Bioequivalence study of fenofibrate 300 mg capsule produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects 
Interventions: Fenofibrate Capsule 300 mg manufactured by PT Kimia Farma Tbk 
INA-WTY4FQX  Complete   Bioequivalence Study of Tenofovir Disoproxil Fumarate/ Lamivudine/ Efavirenz 300 mg/ 300 mg/ 600 mg Film Coated Tablets manufactured by PT Kimia Farma Tbk in comparison with Tenofovir Disoproxil Fumarate/ Lamivudine/ Efavirenz 300 mg/ 300 mg/ 600 mg Tablet, Symfi® manufactured by Mylan Laboratories Limited Hyderabad India for Mylan Specialty L.P. Morgantown, WV 26505 U.S.A; registered trademark of Mylan Pharmaceuticals inc. 
Interventions: Tenofovir Disoproxil Fumarate/ Lamivudine/ Efavirenz 300 mg/ 300 mg/ 600 mg Film Coated Tablets manufactured by PT Kimia Farma Tbk 
INA-WGW2G03  Complete   Bloequivalence siudy of Candesaftan Cilexetil 16 mg Tablet manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories in comparison with Candesartan 16 mg tablet, Blopress@ manufactured by PT Takeda lndonesia, Under license by Takeda Pharmaceutical Company Limited, Osaka, Japan 
Interventions: Candesartan Cilexetil 16 mg Tablet manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories 
INA-6XR43T9  Complete   Bioequivalence Study of 90 mg Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories In Comparison with Brilinta® 90 mg Film Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd., China, Imported by PT. AstraZeneca Indonesia 
Interventions: Ticagrelor Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories 
INA-NF6NED0  Complete   Bioequivalence Study of Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals in Comparison with Xarelto® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by Bayer AG, Germany Imported by PT Bayer Indonesia 
Interventions: Rivatrop® 20 mg (Rivaroxaban 20 mg) Film Coated Tablet Produced by PT Tropica Mas Pharmaceuticals 
INA-AKMGWX0  Complete   Bioequivalence Study of 500 mg Valaciclovir (Zostavir®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Valtrex 500 mg Film Coated Tablets Manufactured by Glaxo Wellcome, S.A., Spain, Imported by PT. Glaxo Wellcome Indonesia 
Interventions: Zostavir 500 film coated tablet manufactured by PT Novell Pharmaceutical Laboratories 
INA-SNNZ463  Complete   Bioequivalence Study of Sildenafil 100 mg Film-Coated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Viagra 100 mg Film-Coated Tablet Manufactured by Pfizer 
Interventions: Sildenafil 100 mg Film-Coated Tablet Manufactured by PT. Kimia Farma Tbk 
INA-ZRSRGQX  Complete   Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT. Kimia Farma Tbk Compared to Movi-Cox® 15 mg Tablet Manufactured by PT. Boehringer Ingelheim Indonesia 
Interventions: Meloxicam 15 mg Tablet Manufactured by PT. Kimia Farma Tbk 
INA-F69KPE1  Complete   Bioequivalence Study of Salbutamol 4 mg Tablet Manufactured by PT. Kimia Farma Tbk Compared to Ventolin® 2x2 mg Tablet Manufactured by PT. Glaxo Wellcome Indonesia 
Interventions: Salbutamol 4 mg Tablet Manufactured by PT. Kimia Farma Tbk 
INA-R5A3QDW  Complete   Bioequivalence Study of Moxibat® Film-Coated Tablet Manufactured by PT Interbat in Comparison with Avelox® Film-Coated Tablet Manufactured by Bayer AG, Leverkusen – Germany, Imported by PT Bayer Indonesia, Depok – Indonesia 
Interventions: Moxibat® film-coated tablet manufactured by PT Interbat 
INA-YX3MOEO  Complete   Bioequivalence Study of Pyrazinamide 500 mg Caplets (Pyratibi® 500 Caplet) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Pyrazinamide Tablets, USP 500 mg Manufactured by Mikart Inc., Atlanta, Georgia for Versapharm Inc. - An Akorn Company, Lake Forest, Illinois, USA 
Interventions: Pyratibi® 500 Caplet manufactured by PT IFARS Pharmaceutical Laboratories 
INA-W66OCDO  Complete   Bioequivalence Study of Pyrazinamide 500 mg Caplets (Pyratibi® 500 Caplet) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Pyrazinamide Tablets, USP 500 mg Manufactured by Mikart Inc., Atlanta, Georgia for Versapharm Inc. - An Akorn Company, Lake Forest, Illinois, USA 
Interventions: Pyratibi® 500 Caplet manufactured by PT IFARS Pharmaceutical Laboratories 
INA-6N5X3HX  Complete   Bioequivalence Study of Pyrazinamide 500 mg Caplets (Pyratibi® 500 Caplet) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Pyrazinamide Tablets, USP 500 mg Manufactured by Mikart Inc., Atlanta, Georgia for Versapharm Inc. - An Akorn Company, Lake Forest, Illinois, USA 
Interventions: Pyratibi® 500 Caplet manufactured by PT IFARS Pharmaceutical Laboratories 
INA-F3TTW81  Complete   Bioequivalence study of trimetazidine dihydrochloride 35 mg modified release tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in comparison with the comparator drug (Vastarel® 35 mg Modified Release Tablet, Les Laboratoires Servier Industrie, France) when administered under fasting condition in healthy subjects. 
Interventions:  
INA-4FNB2WX  Complete   Bioequivalence Study of Simvastatin Tablet 20 mg Produced by PT Kimia Farma Tbk Compared to Zocor® Tablet 20 mg Produced by Organon Pharma Limited United Kingdom 
Interventions: Simvastatin Tablet 20 mg Produced by PT Kimia Farma Tbk 
INA-PSBS6QF  Complete   Bioequivalence Study of Febuxostat 80 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to Feburic 80 mg Film-Coated Tablet Produced by Patheon France 
Interventions: Febuxostat 80 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk 
INA-HBM0POC  Complete   Bioequivalence Study of Aripiprazole 10 mg Orally Disintegrating Tablets Manufactured by PT. LAPI Laboratories, Cikande - Serang in Comparison with Abilify Discmelt® 10 mg Orally Disintegrating Tablets Manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Republic of Korea, Imported by PT.Otsuka Indonesia. 
Interventions: Aripiprazole 10 mg ODT Manufactured by PT. LAPI Laboratories, Cikande - Serang 
INA-XOQF8PC  Complete   Bioequivalence Study of Amlodipine 10 mg caplet manufactured by PT Guardian Pharmatama in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg caplet manufactured by PT Guardian Pharmatama 
INA-DQXZTQD  Complete   Bioequivalence study of multisource of gabapentin 300 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Neurontin® 300 mg Capsule produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia) when administered under fasting condition in healthy subjects. 
Interventions: Test drug: multisource of gabapentin 300 mg capsule (produced by PT Dexa Medica) Reference drug: Neurontin® 300 mg Capsule (produced by Pfizer Pharmaceutical LLC, Puerto Rico, packaged and released by Pfizer Manufacturing Deutschland GmbH, Germany, imported by PT Pfizer Indonesia, Indonesia) 
INA-H64QL3T  Complete   BIOEQUIVALENCE STUDY OF MELOXICAM 15 MG TABLET PRODUCED BY PT MAHAKAM BETA FARMA IN COMPARISON WITH MOBIC (MELOXICAM 15 MG) TABLET MANUFACTURED BY BOEHRINGER INGELHEIM ELLAS AE, KOROPI, GREECE 
Interventions:  
INA-SGW0RQP  Complete   Bioequivalence Study of 0.25 mg Pramipexole Dihydrochloride Monohydrate (Pramivex®) Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® 0.25 mg Tablets Manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany, Imported by PT. Boehringer Ingelheim, Indonesia 
Interventions: Pramivex 0,25 tablet manufactured by PT Novell Pharmaceutical Laboratories 
INA-8SYC17E  Initial   Bioequivalence Study of Ondansetron 8 mg Tablets Manufactured by PT Mahakam Beta Farma in Comparison with Zofran 8 mg Film-Coated Tablets Manufactured by Aspen Bad Oldesloe GmbH, Germany, Registered and Imported by Novartis Corporation (Malaysia) Sdn. Bhd 
Interventions:  
INA-17ATKA3  Complete   Bioequivalence study of piroxicam 20 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Feldene® 20 mg Capsule produced by Fareva Amboise, France under license of Pfizer Italia S.r.l) when administered under fasting condition in healthy subjects. 
Interventions: Test drug: Piroxicam 20 mg Capsule (produced by PT Dexa Medica, Indonesia) Reference drug: Feldene® 20 mg Capsule (produced by Fareva Amboise, France under license of Pfizer Italia S.r.l) 
INA-NROYK5Q  Complete   bioequivalence study of Rifampicin 600 mg Film Coated Caplet manufactured by PT Bernofarm in comparison with with 2x300 mg Rimactan Capsules manufactured by Sandoz GmbH, Austria 
Interventions: Rifampicin 600 mg Film Coated Caplet manufactured by PT Bernofarm 
INA-C06CQL9  Complete   Bioequivalence Study of Ondansetron Hydrochloride Dihydrate Film-Coated Tablets 8 mg Manufactured by PT Interbat in Comparison with ZofranTM Film-Coated Tablets 8 mg Manufactured by Aspen Bad Oldesloe GmbH, Germany for Novartis Pharma AG, Basle, Switzerland. 
Interventions: Ondansetron Hydrochloride Dihydrate Film-Coated Tablets 8 mg 
INA-QKA3YXR  Complete   Bioequivalence Study of Deferasirox 360 mg Film-Coated Tablets Manufactured by PT. Kalbe Farma Tbk for PT. Global Onkolab Farma in Comparison with Jadenu™ 360 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein AG, Stein, Switzerland. 
Interventions: Deferasirox 360 mg film-coated tablets 
INA-T62XR1K  Complete   Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg Sustained-Release Film-Coated Tablet (Tamiva® SR) Manufactured by PT Interbat in Comparison with Harnal® OCAS 0.4 mg Film-Coated Prolonged Released Tablet Manufactured by Astellas Pharma Europe B.V, The Netherlands, Imported by PT Combiphar, Indonesia. 
Interventions: Tamiva® SR 0.4 mg film-coated tablet 
INA-0YSGS0S  Complete   Bioequivalence Study of Amlodipine 10 mg Tablet Manufactured by PT. Tropica Mas Pharmaceuticals Compared to Norvask 10 mg Tablet Manufactured by PT. Pfizer Indonesia 
Interventions: Amlodipine 10 mg Tablet Manufactured by PT. Tropica Mas Pharmaceuticals 
INA-N0DO4GC  Recruit   Bioequivalence Study of 300 mg Irbesartan / 12.5 mg Hydrochlorothiazide (Co-Irvell®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Coaprovel® Film Coated Tablets (300 mg Irbesartan / 12.5 mg Hydrochlorothiazide) Manufactured by Sanofi Winthrop Industrie, France, Imported By PT. Aventis Pharma, Indonesia, Licensed By Sanofi Clir SNC, France 
Interventions:  
INA-DRO78TB  Initial   Effect of an Epilepsy Education Programme On Parental Knowledge, Medication Adherence, Seizure Recurrence And Quality Of Life In Children With Epilepsy 
Interventions: Before 1 time of education, the patient's family was asked to fill in the respondent data questionnaire, knowledge level questionnaire, medication adherence questionnaire and quality of life questionnaire for approximately 15 minutes. Educational materials will be given directly through a laptop directly to the respondent for 10-15 minutes and 5 minutes of question and answer session. There were 3 times sending educational videos in weeks 2, 3 and 4 and whatsapp reminders to take standardised medication, week 5 evaluation by filling out questionnaires on knowledge level, medication adherence and quality of life. This series of educational programmes was documented in the PEE documentation sheet. 
INA-R32FRPL  Complete   Bioequivalence Study of Ezetimibe 10 mg Caplet (Zetriol®) Manufactured by PT Interbat in Comparison with Ezetrol® 10 mg Tablet Manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico, Packed by Schering-Plough Labo N.V., Belgium, Registered by PT Organon Pharma Indonesia Tbk, Indonesia 
Interventions: Zetriol® 10 mg caplet 
INA-NDSQER6  Complete   BIOEQUIVALENCE STUDY OF AMLODIPINE BESYLATE 10 MG TABLET MANUFACTURED BY PT MEGA LIFESCIENCES INDONESIA IN COMPARISON WITH AMLODIPINE BESYLATE 10 MG TABLET, NORVASK MANUFACTURED BY PT PFIZER INDONESIA 
Interventions: This study aimed was to investigate the bioequivalence study of Amlodipine besylate 10mg Tablet manufactured by PT Mega Lifesciences Indonesia in comparison with Amlodipine besylate 10mg tablet, Norvask manufactured by PT Pfizer Indonesia 
INA-4FTZDCG  Complete   BIOEQUIVALENCE STUDY OF OMEPRAZOLE CPL 20 (OMEPRAZOLE 20 MG) DELAYED RELEASE CAPSULE PRODUCED BY PT ERRITA PHARMA IN COMPARISON WITH LOSEC 20 (OMEPRAZOLE 20 MG) DELAYED RELEASE CAPSULE MANUFACTURED BY CHEPLAPHARM, GERMANY, IMPORTED BY BILCARE GCS 
Interventions: Omeprazole 
INA-ZM65S9E  Complete   Bioequivalence study of fenofibrate 300 mg capsule (Evothyl® 300 mg) produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects 
Interventions: one of test drug (Evothyl® 300 mg Capsule produced by PT Guardian Pharmatama) 
INA-CBE404X  Initial   The Effect of Education Using Audiovisual Animation on the Anxiety Level of Preschool Children Undergoing Surgical Procedures with General Anesthesia 
Interventions: The intervention group will receive education about the details of the process of anesthesia and surgery using a self-produced audiovisual animation, three times, 5 minutes at a time. 
INA-YAGLLLY  Initial   The Effect of Education Using Audiovisual Animation on the Anxiety Level of Preschool Children Undergoing Surgical Procedures with General Anesthesia 
Interventions: The intervention group will receive education about the details of the process of anesthesia and surgery using a self-produced audiovisual animation, three times, 5 minutes at a time. 
INA-D6RBKDP  Complete   Bioequivalence Study of 250 mg Gefitinib Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 250 mg Iressa® Film-Coated Tablets Manufactured by Kagamishi Plant, Nipro Pharma Corporation, Japan, Imported by PT. Astra Zeneca Indonesia 
Interventions: 250 mg Gefitinib film-coated tablets 
INA-NZ052EP  Complete   Bioequivalence Study of Atenolol 50 mg Tablet (Internolol® 50 Tablet) Manufactured by PT Interbat in Comparison with Tenormin® 50 mg Film-Coated Tablet Manufactured by Astrazeneca AB, Swedia 
Interventions: Internolol® 50 mg tablet batch no ZT0287202 (Formula A) and Internolol® 50 mg tablet batch no ZT0287203 (Formula B) 
INA-GL4RHGW  Initial   The effect incubator covers with dampening materials on the physiological responses and sleep patterns of premature babies 
Interventions: Use of an incubator cover with damping material for 12 hours, starting at 19.30 p.m. until 07.30 a.m. 
INA-E3LN5CD  Initial   Technology-based fluid monitoring system 
Interventions: Participants in intervention group will have fluid monitoring using technology-based fluid monitoring system 
INA-86DRC1W  Initial   Development of technology-based fluid monitoring system 
Interventions: Participants in intervention group will have intravenous therapy using technology-based monitoring system 
INA-6YYZQ55  Complete   BIOEQUIVALENCE STUDY OF OMEPRAZOLE CPL 20 (OMEPRAZOLE 20 MG) DELAYED RELEASE CAPSULE PRODUCED BY PT ERRITA PHARMA IN COMPARISON WITH LOSEC 20 (OMEPRAZOLE 20 MG) DELAYED RELEASE CAPSULE MANUFACTURED BY CHEPLAPHARM, GERMANY, IMPORTED BY BILCARE GCS 
Interventions: OMEPRAZOLE CPL 20 (OMEPRAZOLE 20 MG) DELAYED RELEASE CAPSULE PRODUCED BY PT ERRITA PHARMA 
INA-XB4E0PR  Initial   The Effect of Parental Holding and Therapeutic Play with Spiky Ball on Postoperative Anxiety and Physiological responses of children in the Recovery Room 
Interventions: In this study, 3 groups were observed, the parental holding intervention group, the spiky ball playing intervention group, and the control group which received the standard intervention of the presence of parents next to the patient. In this study, anxiety and physiological responses (oxygen saturation, heart rate, respiratory rate and body temperature) were measured 15 minutes before the intervention and the first minute after the 15 minute intervention. 
INA-4HSXNOP  Initial   EFFECTIVENESS OF INTRA-HOSPITAL TRANSFER WITH S.T.A.B.L.E METHOD APPROACH ON PHYSIOLOGICAL RESPONSES OF NEWBORNS AND PARENTS EMOTIONAL STATUS 
Interventions: Physiological status checks are carried out after the baby is born by checking vital signs and blood sugar, then intervening with the STABLE method according to the results of the examination. Hypoglycemia: Collaboration with doctor to administer D10%, hypothermia: infants 2500 gr, age 0-24 hours: 33oC, BW >2500 gr, age >24 hours: 32oC. Airway: Ensure the baby's airway is clear. Breathing: Ensure the oxygenation needs of the LBW (oxygen administration, CPAP insertion, or intubation). Parental support, explained in terms of: the reason for the transfer, facilities needed by the baby, education to parents about the transportation team and the infant's care plan, provide opportunities for parents to ask questions and provide answers to any questions the nurse can answer, parents who have been given an explanation according to the STABLE method are then asked to complete the SAI questionnaire. 
INA-XPCLXH3  Complete   Bioequivalence study of Amlodipine 10 mg tablet, Comdipin® manufactured by PT Combiphar in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet, Comdipin® manufactured by PT Combiphar 
INA-5RTPNL1  Complete   INAVAC - UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster in Adolescent 
Interventions: INAVAC (Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg) 
INA-B1YCNGR  Recruit   INAVAC - UNAIR Inactivated COVID-19 Vaccine in Healthy Population Aged 12 to 17 Years Old 
Interventions: INAVAC (Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg) 
INA-P3MEKNY  Complete   bioequivalence study of Rosuvastatin 20 mg Film-Coated Tablet manufactured by PT Otto Pharmaceutical Industries in comparison with Rosuvastatin 20 mg Film-Coated Tablet, Crestor manufactured by IPR Pharmaceuticals Inc. Puerto Rico for AstraZeneca UK Limited, United Kingdom; packaged and released by AstraZeneca Pharmaceutical Co. Ltd, China; imported by PT AstraZeneca Indonesia 
Interventions: Rosuvastatin 20 mg Film-Coated Tablet manufactured by PT Otto Pharmaceutical Industries 
INA-PSPGKG0  Complete   Bioequivalence Study of Escitalopram Oxalate (Escitalopram 10 mg) Film Coated Tablet Produced by PT Nulab Pharmaceutical Indonesia, Registered by PT Nulab Pharmaceutical Indonesia in Comparison with Cipralex® (Escitalopram 10 mg) Film Coated Tablet Manufactured by H Lundbeck A/S, Valby, Denmark, Imported by PT Pyridam Farma Tbk, Jakarta - Indonesia 
Interventions: Escitalopram Oxalate 10 mg Film Coated Tablet 
INA-7KXNHQ5  Complete   Bioequivalence Study of ALMEN® 5 mg (Donepezil Hydrochloride 5 mg) Film Coated Tablet Produced by PT Guardian Pharmatama, Registered by PT Guardian Pharmatama in Comparison with ARICEPT® EVESS 5 mg (Donepezil Hydrochloride 5 mg) Orodispersible Tablet Manufactured by Bushu Pharmaceutical Ltd, Saitama-Ken, Japan, Packaged and Released by Interthai Pharmaceutical Ltd, Bangkok, Thailand, Imported by PT Eisai Indonesia, Bogor, Indonesia 
Interventions: Donepezil Hydrochloride 5 mg ® manufactured by PT. Guardian Pharmatama 
INA-X2O2802  Complete   Bioequivalence Study of 80 mg Acetylsalicylic Acid Enteric Coated Tablet, Manufactured by PT Pharos Indonesia (Ascardia®) in Comparison with the Innovator’s 100 mg Acetylsalicylic Acid Enteric Coated Tablet (Cardio Aspirin®), Manufactured by Bayer AG, Leverkusen-Germany for Bayer Consumer Care AG, Switzerland, Imported by PT Bayer Indonesia, Depok-Indonesia 
Interventions: Single dose, 5 tablets of 80 mg Acetylsalicylic Acid enteric coated tablet (Ascardia®), Manufactured by PT Pharos Indonesia 
INA-1ZRT75Y  Complete   BIOEQUIVALENCE STUDY OF GEMFIBROZIL 300 MG CAPSULE MANUFACTURED BY PT PHAPROS TBK IN COMPARISON WITH LOPID® 300 MG CAPSULE (GEMFIBROZIL 300 MG) MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY FOR PFIZER LTD, UK IN HEALTHY SUBJECTS 
Interventions: Single dose of Gemfibrozil 300 mg Capsule, Manufactured by PT Phapros Tbk 
INA-GZ8CDAB  Complete   Bioequivalence Study of 20 mg Rivaroxaban Film Coated Tablets, Manufactured by PT. Lapi Laboratories (Rivaroxaban 20 mg (LAPI)) in Comparison with the Innovator’s Film Coated Tablets (Xarelto®), Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported by PT. Bayer Indonesia, Depok, Indonesia 
Interventions: Single dose of one film coated tablet of 20 mg Rivaroxaban (Rivaroxaban 20 mg (LAPI)), Manufactured PT. Lapi Laboratories 
INA-FR65LNO  Complete   Bioequivalence study of 20 mg Omeprazole Capsules Manufactured by PT. Darya-Varia Laboratoria Tbk. (Ozid®) In Comparison with the Innovator’s Capsules (Losec®) Manufactured by AstraZeneca AB, Sodertalje, Sweden, Imported by AstraZeneca Pharmaceuticals (Phils), Inc. 16/F Net 3 Center, Cor. 3rd Ave & 30th St. Bonifacio Global City, Taguig, Philippines 
Interventions: Single dose of one capsules of 20 mg Omeprazole (Ozid®), Manufactured PT Darya-Varia Laboratoria Tbk. 
INA-Y9PKF04  Complete   Bioequivalence Study of 100 mg/5 mL Cefixime Trihydrate Dry Syrup, Manufactured by PT. Pharma Laboratories (CEFIXIME TRIHYDRATE) in Comparison with the Innovator’s Oral Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal, Canada H9R 2Y6, Registered Trademark of Astellas Pharma Inc., Osaka, Japan 
Interventions: Single dose of 10 mL of reconstituted 100 mg/5 mL Cefixime Dry Syrup (CEFIXIME TRIHYDRATE), Manufactured PT Pharma Laboratories 
INA-FTKG6HY  Complete   Bioequivalence Study of 15 mg Aripiprazole Tablets, Manufactured by PT. Amarox Pharma Global (Aripiprazole) in Comparison with the Innovator’s Tablets (Abilify®), Manufactured by Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea, under Authorization of Otsuka Pharmaceutical Co., Ltd., Japan, Imported by PT. Otsuka Indonesia, Malang, Indonesia 
Interventions: Single dose of one tablet of 15 mg (Aripiprazole), Manufactured PT Amarox Pharma Global 
INA-E5M01FS  Complete   Bioequivalence Study of 5 mg Aripiprazole Tablets, Manufactured by PT. Amarox Pharma Global (Aripiprazole) in Comparison with the Innovator’s Tablets (Abilify®), Manufactured by Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea, under Authorization of Otsuka Pharmaceutical Co., Ltd., Japan, Imported by PT. Otsuka Indonesia, Malang, Indonesia 
Interventions: Single dose of one tablet of 20 mg Aripiprazole (Aripiprazole), Manufactured PT Amarox Pharma Global 
INA-SZFAXCW  Complete   Bioequivalence Study of 40 mg Rosuvastatin Film Coated Caplets, Manufactured by PT. Dipa Pharmalab Intersains (Suvesco®) in Comparison with the Innovator’s Film Coated Tablets (Crestor®), Manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd. Wuxi, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Cikarang, Bekasi, Indonesia 
Interventions: Single dose of one film coated tablet of 20 mg Rosuvastatin (Suvesco®), Manufactured PT Dipa Pharmalab Intersains 
INA-4DG6K4T  Complete   Bioequivalence Study of 20 mg Tadalafil Film Coated Tablets, Manufactured by PT. Lapi Laboratories (Tadalafil LAPI) in Comparison with the Innovator’s Film Coated Tablets (Cialis®), Manufactured by Lilly del Caribe Inc., Puerto Rico for Lilly S.A. Alcobendas, Madrid – Spain, Registered by PT. Bayer Indonesia, Depok, Indonesia 
Interventions: Single dose of one film coated tablet of 20 mg Tadalafil (Tadalafil LAPI), Manufactured PT Lapi Laboratories 
INA-HG0ZNT3  Complete   Bioequivalence Study of 20 mg Rivaroxaban Film Coated Tablets, Manufactured by PT. Dipa Pharmalab Intersains (Rivaco® 20) In Comparison with the Innovator’s Film Coated Tablets (Xarelto®), Manufactured by Bayer Pharma AG, Leverkusen – Germany, Imported by PT. Bayer Indonesia, Depok-Indonesia 
Interventions: Single dose of one film coated tablet of 20 mg Rivaroxaban (Rivaco®20), Manufactured PT Dipa Pharmalab Intersains 
INA-SDZMO78  Complete   Bioequivalence study of 50 mg Diclofenac Sodium Enteric Coated Tablets Manufactured by PT. Samco Farma (SAMCOFENAC 50) In Comparison With The Innovator’s Enteric Coated Tablets (Voltaren 50) Manufactured by PT. Novartis Indonesia, Jakarta, Indonesia, Under License of Novartis Pharma AG Basel, Switzerland 
Interventions: Single dose of one enteric coated tablet of 100 mg Sildenafil (SAMCOFENAC®50), Manufactured pt Samco Farma 
INA-LG5G3SZ  Complete   Bioequivalence Study of 0.4 mg Tamsulosin Hydrochloride Sustained Release Tablets, Manufactured by PT. Lapi Laboratories (Tamsulosin LAPI) in Comparison with the Innovator’s Oral Controlled Absorption System (OCAS) Tablets (Harnal®), Manufactured by Astellas Pharma Europe B.V, The Netherlands, Imported by PT. Combiphar, Bandung, Indonesia 
Interventions: Single dose of 0.4 mg Tamsulosin Hydrochloride Sustained Release Tablets (Tamsulosin LAPI), Manufactured by PT Lapi Laboratories 
INA-KA433KE  Complete   Bioequivalence Study of 40 mg Pantoprazole Enteric Coated Tablets, Manufactured by PT. Guardian Pharmatama for PT. Nulab Pharmaceutical Indonesia (Pantoprazole) in Comparison with the Innovator’s Gastro Resistant Tablet (Pantozol®), Manufactured by Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70-98 16151 Oranienburg Germany, Imported by PT. Takeda Indonesia 
Interventions: Single dose of 40 mg Pantoprazole Enteric Coated Tablets, Manufactured by PT. Guardian Pharmatama for PT. Nulab Pharmaceutical Indonesia 
INA-2NOQY9F  Initial   Web-based educational program to increase the knowledge of the younger generation about stunting prevention 
Interventions: The participants in intervention group will have educational program using web-based platform for 12 videos individually. Duration of the videos is about 2-7 minutes. The participants have 3 weeks to watch all the videos. The content of the videos as follow: Reproductive organs, Prevention of obesity in teenagers, The impacts of smoking (semen quality), The impacts of smoking (stunting), Health hygiene of reproductive organs, Promiscuity in teenagers, The impacts of promiscuity, Avoiding promiscuity, The impacts of early marriage, The impact of excessive glucose consumption, Iron and teenager's health, Fast food and it impacts on health. 
INA-2W2837E  Complete   Bioequivalence study of clozapine 25 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany) when administered as a 12.5 mg dose under fasting condition in healthy subjects 
Interventions: Test drug: Clozapine 25 mg Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Leponex® 25 mg Tablet produced by Mylan Hungary Kft., Hungary licensed by Viatris Healthcare GmbH, Germany 
INA-DKHR6TX  Complete   Bioequivalence study of 4 mg/5 mL Methylprednisolone Suspensions, Manufactured by PT. Lapi Laboratories (Lameson®) In Comparison with The Innovator’s 4 mg Tablets (Medrol®) Manufactured by Pfizer Italia S.r.l., Ascoli, Italy, Imported by PT. Pfizer Indonesia, Jakarta, Indonesia 
Interventions: Single dose of 10 mL of 4 mg/5 mL Methylprednisolone Suspensions (Lameson®), Manufactured by PT Lapi Laboratories 
INA-7YL6Z1N  Complete   Bioequivalence Study of Dapagliflozin 10 mg Film-Coated Tablet Manufactured by PT Interbat in Comparison with Forxiga® 10 mg Film-Coated Tablet Manufactured by AstraZeneca UK Limited, Imported by PT AstraZeneca Indonesia. 
Interventions: Dapagliflozin® 10 mg Film-Coated Tablet 
INA-7D6TG52  Complete   Bioequivalence Study of 100 mg Lamotrigine Tablets, Manufactured by PT. Pharos Indonesia (Lamiros®) in Comparison with the Innovator’s Tablets (Lamictal), Manufactured by GlaxoSmithKline Pharmaceuticals S.A, Poznan-Poland, Imported by PT. Glaxo Wellcome Indonesia, Jakarta-Indonesia 
Interventions: Single dose of 100 mg Lamotrigine Tablets (Lamiros®) Manufactured by PT Pharos Indonesia 
INA-TBT6003  Complete   INAVAC - UNAIR Inactivated COVID-19 Vaccine as Homologue Booster 
Interventions: INAVAC (Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg) 
INA-SKSBP7O  Complete   Bioequivalence study of 100 mg/5mL Cefixime Dry Syrup, Manufactured by PT. Lapi Laboratories (Cefila® DS) In Comparison with the Innovator’s Oral Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal Canada H9R 2Y6, Registered Trademark of Astellas Pharma Inc., Osaka - Japan 
Interventions: Single dose of 10 mL of reconstituted 100 mg/5mL Cefixime Dry Syrup (Cefila® DS), Manufactured by PT. Lapi Laboratories 
INA-PZAMXFD  Complete   Bioequivalence Study of 10 mg Domperidone Orally Disintegrating Tablet, Manufactured by PT. Guardian Pharmatama (Galflux® ODT) in Comparison with the Innovator’s Film Coated Tablets (Motilium®), Manufactured by PT. Taisho Pharmaceutical Indonesia Tbk., Depok - Indonesia, Under License by Janssen Pharmaceutica, Beerse - Belgium, Division of Johnson & Johnson 
Interventions: Single dose of 10 mg Domperidone Orally Disintegrating Tablet (Galflux® ODT), Manufactured by PT Guardian Pharmatama 
INA-K0M1AAA  Complete   Bioequivalence study of Vastofar® 40 (Atorvastatin 40 mg) film coated caplet produced by PT IFARS Pharmaceutical Laboratories in comparison with Lipitor® (Atorvastatin 40 mg) film coated tablet manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, USA, imported by PT Pfizer Indonesia 
Interventions: The reference drug was Lipitor® (Atorvastatin 40 mg) film coated tablet manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, USA, imported by PT Pfizer Indonesia. The test drug was Vastofar® 40 (Atorvastatin 40 mg) film coated caplet produced by PT IFARS Pharmaceutical Laboratories. In the morning of the sampling as scheduled, subjects were given one dose of Atotvastatin products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position 
INA-BC98F9Y  Complete   Bioequivalence study of 100 mg Sildenafil Citrate Film Coated Tablets Manufactured by PT. Prima Medika Laboratories (Rozgra®) In Comparison with the Innovator’s 100 mg Sildenafil Citrate Film Coated Tablets (Viagra®), Manufactured by Fareva Ambiose, Poce-sur-Cisse, France, Imported by PT. Pfizer Indonesia, Jakarta, Indonesia 
Interventions: single dose of 100 mg Sildenafil Citrate (Rozgra@), Manufactured by PT Prima Medika Laboratories 
INA-94M1E19  Complete   Bioequivalence Study of Ketoconazole 200 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Ketoconazole, USP 200 mg Tablet Produced by Taro Pharmaceutical Industries Ltd. Distributed by Taro Pharmaceuticals U.S.A., Inc. United States 
Interventions: Ketoconazole 200 mg Tablet produced by PT Trifa Raya Laboratories 
INA-RY6TL0A  Complete   Bioequivalence Study of Alprazolam 1 mg Tablets Manufactured by PT Kimia Farma Tbk in Comparison with Xanax® 1 mg Tablets Manufactured by Pfizer Pharmaceutical LLC, Barceloneta, Puerto Rico, Imported by PT Pfizer Indonesia, Jakarta, Indonesia. 
Interventions: Alprazolam 1 mg Tablets Manufactured by PT Kimia Farma Tbk 
INA-2D89546  Complete   Bioequivalence study of Candesartan 16 mg tablet manufactured by PT Hexpharm Jaya Laboratories in comparison with Candesartan 16 mg tablet, Blopress® manufactured by PT Takeda Indonesia, Under license by Takeda Pharmaceutical Company Limited, Osaka, Japan 
Interventions: Candesartan Cilexetil 16 mg 
INA-GBFPHEX  Complete   BIOEQUIVALENCE STUDY OF KETOCONAZOLE 200 MG TABLET PRODUCED BY PT KIMIA FARMA TBK COMPARED TO KETOCONAZOLE TABLET, USP 200 MG EX TARO PHARMACEUTICAL INDUSTRIES Ltd HAIFA BAY, ISRAEL 
Interventions: Ketoconazole 200 mg Tablet Produced by PT Kimia Farma Tbk (Test Drug) Ketoconazole Tablet, USP 200 mg ex Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel (Comparator Drug) 
INA-ZMWGFQR  Complete   Bioequivalence Study of Ethambutol 500 mg Film-coated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 5x100 mg Film-coated Tablet Manufactured by Labatec Pharma S.A, Meyrin Geneva Swiss 
Interventions: Ethambutol 500 mg Film-coated Tablet Manufactured by PT. Kimia Farma Tbk 
INA-4GPX4FY  Complete   Bioequivalence Study of Pregabalin 150 mg Capsules Manufactured by PT Kimia Farma Tbk in Comparison with Lyrica®150 mg Capsules Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta. 
Interventions: PREGABALIN 150 MG CAPSULES MANUFACTURED BY PT KIMIA FARMA TBK 
INA_2ALA8PR  Complete   Bioequivalence study of Efavirenz 600 mg Film-Coated Tablet manufactured by PT Kimia Farma Tbk in comparison with Efavirenz 600 mg tablet, Stocrin® manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd, China; registered by MSD Pharma (Singapore) Pte Ltd 
Interventions: Efavirenz Film Coated Tablet manufactured by PT Kimia Farma Tbk. 
INA-PPDOA2X  Complete   Bioequivalence study of tenofovir disoproxil fumarate 300 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Viread® 300 mg Tablet produced by Takeda GmbH, Germany, for Gilead Sciences International Ltd, UK) 
Interventions: Tenofovir Disoproxil Fumarate 300 mg Film coated Tablet manufactured by PT Kimia Farma Tbk. 
INA-47T8310  Complete   Bioequivalence Study of Ciprofloxacin HCl 500 mg Film-Coated Tablets Manufactured by PT Hexpharm Jaya in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer AG, Kaiser-Wilhelm-Allee, 51368, Leverkusen, Germany. 
Interventions: Ciprofloxacin HCl 500 mg Film-Coated Tablets 
INA-H7BTHKZ  Complete   Bioequivalence Study of 100 mg Sitagliptin Film-Coated Film-coated tablets Manufactured by PT. Tropica Mas Pharmaceuticals in Comparison with 100 mg Januvia™ Film-Coated Film-coated tablets Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan, Indonesia 
Interventions: Sitagliptin 100 mg film-coated tablets 
INA-QHXFS0X  Complete   Bioequivalence study of furosemide 40 mg tablet produced by PT Indofarma Tbk. in comparison with the comparator drug (Lasix® 40 mg Tablet, PT Aventis Pharma, Indonesia) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug of furosemide 40 mg tablet produced by PT Indofarma Tbk. or one comparator drug (Lasix® 40 mg Tablet produced by PT Aventis Pharma, Indonesia) given with 200 mL of water and swallowed whole without chewing. 
INA-G1SOG60  Complete   BIOEQUIVALENCE STUDY OF AMLODIPINE 10 MG TABLET PRODUCED BY PT MAHAKAM BETA FARMA IN COMPARISON WITH NORVASK® (AMLODIPINE 10 MG) TABLET MANUFACTURED BY PT PFIZER INDONESIA. 
Interventions: Bioequivalence study of Amlodipine 10 mg tablet produced by PT Mahakam Beta Farma in comparison with Norvask® (Amlodipine 10 mg) tablet manufactured by PT Pfizer Indonesia. 
INA-CB02R0O  Complete   Bioequivalence study of Ciprofloxacin 500 mg Film Coated Tablets, Ciflos® manufactured by PT Guardian Pharmatama in comparison with Ciprofloxacin 500 mg Film Coated Tablets, Ciproxine® Marketing Authorisation holder by Bayer SA-NV, Belgium 
Interventions: Ciflos® manufactured by PT Guardian Pharmatama 
INA-OOR8AXF  Recruit   THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA 
Interventions: The IFSM program will be administered to a cohort consisting of around 15-17 dyads, comprised of persons with suboptimal glycemic control and their respective family members. Consequently, the intervention group will be partitioned into two smaller subgroups. The researchers will invite the experimental participants to join the activities which consist of several activities, as follows:. 1. First (1st) Week: Face-to-Face Program (Friday and Saturday). Activities 1: Diabetes knowledge training. A 90-minute structured group education training that aims to improve the understanding of factual information about T2DM and self-management behaviors and their rationales will be conducted in the first week. The primary Investigator (PI) and co-investigators (Co-PI) will provide the education session, and module 01 will be given to the participants. The series of activities are, as follows; 1) The researchers build trusted relationships by implementing building learning commitment (BLC) through an introduction, ice-breaking, creating daily session objectives and expectations, and then posting on the blackboard in the class (5 minutes); 2) Providing short quizzes to determine their basic knowledge; (5 minutes); 3) Providing diabetes information: definition, diagnosis, signs and symptoms, complications with interesting images and a diabetes video presentation; (35 minutes); 4) The PI provides information about self-management behaviors and their rationale b: physical exercises, Diabetes Diet, Diabetes medication, and blood glucose monitoring by using Canva presentation design and infographics; (40 minutes); 5) The participants will be helped to evaluate their daily objectives by playing diabetes word games with answers (5 minutes). Activities 2: Self-Efficacy training. This session aims to enhance people with uncontrolled T2DM and their family’s belief or confidence to engage and maintain self-management behaviours to achieve glycemic control and improve the HRQoL. It will last 30 minutes and include the following activities; 1) Sharing and reflecting on the uncontrolled T2DM and their families’ beliefs about diabetes and DSM practices; 2) The researchers guide the discussion to change negative perceptions of diabetes and reinforce positive comments; 3) Sharing successful experiences from diabetic patients who experience the benefits of self-management behaviors and maintain their glycemic control. 2. Second (2nd) week: Self-regulation Training (Saturday) This third session will be carried out in 120-minute meetings in the second week (Friday). This session is designed to achieve change in diabetes self-management behaviours of people with uncontrolled T2DM and their families by practicing self-regulation skills and abilities. Therefore, to achieve these goals, the activities will be; 1) The researchers assist those with uncontrolled T2DM and their families in developing personal and family goals for self-management of diabetes (10 minutes); 2) The PI guide for reflective thinking to identify the possible barriers and challenges of DSM (5 minutes); 3) The researchers present a weekly meal planning form and direct individuals with uncontrolled T2DM and their families to create calorie-based meal plans for their diabetes (25 minutes); 4) The researchers present the weekly exercise planning form and instruct individuals with uncontrolled type 2 diabetes (T2DM) and their families on how to create their weekly activity planners (150 minutes of walking per week or 30 minutes per day). (15 minutes); 5) The researchers explain the planning form for self-monitoring blood sugar levels and assist persons with uncontrolled T2DM and their families in creating their planner (5 minutes); 6) The researchers explain the diabetes medication diary and assist persons with uncontrolled T2DM and their families in creating planners (5 Minutes); 7) The researchers give the families instructions on how to use and fill out the Diabetes Self-Management Monitoring Checklist (5 minutes); and 8) Talk about the family's responsibilities in SMB, such as taking patients to appointments, preparing food, rescheduling time for meals, complying with many kinds of medicine, and emotional support to cope with the long-term follow-up care of diabetes helping patients, and initiating change in exercise (10 minutes) 3. Week 3, 5, 7, and 9: Family phone calls (every Tuesday) This program aims to promote family discussion and provide ongoing encouragement for SMB performance. The PI and co-PI will make 15-20-minute phone calls to the families in weeks 3, 5, 7, 9, and 11. Week 3: Set up a situation that is convenient for phone calls, listen attentively, and carefully assess each person's weekly meal plan, weekly exercise schedule, diabetes medications, and blood sugar monitoring on week 3. Do they adhere to the strategy? amplify any form of accomplishment. Additionally, the phone conversations highlight any obstacles or hurdles to implementing the DSM weekly plan and serve as a motivator and reminder of the diabetes SMB's key message (table 01). Week 5: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 03 and 04. Discuss the challenges or progress, provide motivation, and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 7: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 05 and 06. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 9: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Week 11: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Moreover, the assessment of diabetes self-management behaviors acquired by the participant from all these weeks by checking their weekly or monthly plan of DSM. 4. Week 4, 6, 8, 10, and 12; Delivering the SMB infographics (Monday, Wednesday, and Friday) Several SMB infographics and motivational messages will be delivered every Monday, Wednesday, and Friday which aim to motivate and remind them to keep performing the SMB (Appendix B). The SMB infographic will be sent at around 12-1 PM and will be checked at around 6 PM. Reminder messages to read the cards will be sent at around 6.30 PM. The diabetes infographics that will be delivered to WA groups involve diabetes medication, physical exercise: healthy eating, blood sugar monitoring, and family roles. 
INA-OZQWN67  Complete   Bioequivalence study of methyldopa 250 mg tablets (Dopamet) produced by PT Actavis Indonesia in comparison with the comparator product (Aldomet® 250 mg Tablets, Aspen Pharmacare Australia Pty Ltd, Australia) 
Interventions:  
INA-TPTK7G5  Complete   bioequivalence study of Gabapentin 300 mg capsule, Gabiron manufactured by PT Amarox Pharma Global in comparison with Gabapentin 300 mg capsule, Neurontin® manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico; Packaged and released by : Pfizer Manufacturing Deutschland GmBH, Betriebsstatte Freiburg, Germany; Imported by : PT Pfizer Indonesia, Jakarta, Indonesia 
Interventions: Gabapentin 300 mg capsule, Gabiron manufactured by PT Amarox Pharma Global 
INA-3GA758K  Complete   Bioequivalence study of telmisartan 80 mg tablet produced by PT Amarox Pharma Global in comparison with the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one tablet of the test drug (telmisartan 80 mg tablet produced by PT Amarox Pharma Global) or one tablet of the comparator drug (Micardis® 80 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Bogor, Indonesia) given with 200 mL of water and swallowed whole without chewing. 
INA-WZXQFTT  Complete   Bioequivalence Study of 10 mg Olanzapine Film Coated Tablet, Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia (Remital®) in Comparison with the Innovator’s Film Coated Tablet (Zyprexa®), Manufactured or Registered by Eli Lilly (Suisse) S.A., Vernier/Gerneve 
Interventions: Single dose of 10 mg Olanzapine Film Coated Tablet (Remital®), Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia 
INA-GRZZKFS  Complete   Bioequivalence Study of Pregabalin 150 mg Capsule Manufactured by PT Interbat in Comparison with Lyrica® 150 mg Capsule Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, Imported by PT Pfizer Indonesia, Jakarta, Indonesia. 
Interventions: Pregabalin 150 mg capsule 
INA-5DF6BN4  Complete   Bioequivalence Study of Pyrazinamide 500 mg Caplets (Pyratibi® 500 Caplet) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Pyrazinamide Tablets, USP 500 mg Manufactured by Mikart Inc., Atlanta, Georgia for Versapharm Inc. - An Akorn Company, Lake Forest, Illinois, USA. 
Interventions: Pyrazinamide 500 mg caplets (Pyratibi® 500 Caplet) 
INA-PYY2EYF  Complete   Bioequivalence Study of Triphasic Oral Contraceptive of Levonorgestrel and Ethinyl Estradiol Sugar-Coated Tablet Manufactured by PT. Sunthi Sepuri (Trinordiol-28®) in Comparison with Triquilar® ED Sugar-Coated Tablet Manufactured in Germany for Bayer Australia Ltd. 
Interventions: Trinordiol-28® 
INA-CE3S97A  Complete   Bioequivalence Study of Bisoprolol 5 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared to Concor® 5 mg Film-Coated Tablet Produced by PT Merck Tbk Indonesia 
Interventions: The reference drug was Concor® 5 mg Film-coated Tablet produced by PT Merck Tbk, Jakarta, Indonesia, batch number E1006323, manufacturing date on Juny 16th 2022, expired date on Juny 14th 2025. The test drug was Bisoprolol Fumarate 5 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number B01F3394, manufacturing date Juny 14th 2023, Expired date Juny 14th 2025. Starting at 07.00 on the first day, the subjects are given the investigational drug (1 tablet of 5 mg Bisoprolol) or the comparator drug (1 tablet of 5 mg Concor®) with 220 mL of water while sitting. The subjects are asked to maintain an upright position, either standing or sitting, for 1 hour after drug administration. 
INA-MWZQTNN  Complete   Bioequivalence study of rivaroxaban 20 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects. 
Interventions: Test drug: Rivaroxaban 20 mg Film-Coated Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Xarelto® 20 mg Film-Coated Tablet (produced by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) 
INA-4XZAXH8  Complete   Bioequivalence study of rivaroxaban 10 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Xarelto® 10 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fasting condition in healthy subjects. 
Interventions: Test drug: Rivaroxaban 10 mg Film-Coated Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Xarelto® 10 mg Film-Coated Tablet (produced by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) 
INA-Y6CT9L0  Complete   Identifikasi Faktor Risiko dan Uji Efektivitas Antioksidan Imunomodulator Madu Temulawak-jinten hitam Terhadap Anak Stunting di Kabupaten Cirebon 
Interventions: Intervensi adalah pemberian madu temulawakjinten hitam pada balita stunting dengan dosis sehari 1 sendok teh selama 4 bulan. Pengambilan darah pertama sebanyak 3 cc sebelum perlakuan, dan pengambilan darah kedua setelah 4 bulan pemberian madu. Parameter yang diukur adalah kadar Hb, Leukosit, trombosit, Superoxide dismutase, Catalase, Glutation peroksidase, CD4, IgM, interleukin-1, Insulin like Growth Factor dan parameter fisik BB, TB, LL, dan LK 
INA-PGABK49  Complete   Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands. 
Interventions: The reference drug was the market available Zorvolex 35 capsule, batch number MF 1391; manufacturing date June 2019; expiration date June 2021 The test drug was Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala, batch number LK 1831; manufacturing date November 2020; expiration date November 2022. In the morning of the sampling as scheduled, subjects were given one dose of Diclofenac Acid products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. 
INA-GMKKZQY  Complete   Bioequivalence study of Cefixime® 200 mg capsule produced by PT Dexa Medica in comparison with the comparator drug (Cefspan® 100 mg Capsule, manufactured by PT Dankos Farma, Indonesia for PT Kalbe Farma Tbk., Indonesia under license of Astellas Pharma Inc., Osaka, Japan) 
Interventions: Test drug: Cefixime® 200 mg Capsule (produced by PT Dexa Medica, Indonesia) Reference drug: Cefspan® 100 mg Capsule (produced by PT Dankos Farma, Indonesia for PT Kalbe Farma Tbk., Indonesia under license of Astellas Pharma Inc., Osaka, Japan) 
INA-DNYCXYM  Complete   UJI BIOEKIVALENSI KAPLET SANPRIMA® FORTE (TRIMETOPRIM 160 mg DAN SULFAMETOKSAZOL 800 mg) PRODUKSI PT SANBE FARMA DIBANDINGKAN TERHADAP TABLET BACTRIM® 160 mg/800 mg (TRIMETOPRIM 160 mg DAN SULFAMETOKSAZOL 800 mg) PRODUKSI EUMEDICA PHARMACEUTICALS GmbH, JERMAN PADA SUBJEK SEHAT 
Interventions: Penelitian yang dilakukan adalah penelitian bioekivalensi dosis tunggal. Penelitian dilakukan dengan desain acak, single blind, dan menyilang dalam 2 periode (two-way crossover design) menggunakan kaplet sanprima® forte (trimetoprim 160 mg dan sulfametoksazol 800 mg) produksi pt sanbe farma dibandingkan terhadap tablet bactrim® 160 mg/800 mg (trimetoprim 160 mg dan sulfametoksazol 800 mg) produksi eumedica pharmaceuticals gmbh, Jerman. 
INA-2R3FFWT  Complete   Bioequivalence study of multisourced of amlodipine besylate 10 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia). 
Interventions: Test drug: Amlodipine besylate 10 mg tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Norvask® 10 mg Tablet (produced by PT Pfizer Indonesia) 
INA-S1XRX5T  Complete   Bioequivalence study of Clobazam 10 mg Tablet produced by PT Dexa Medica in comparison with the comparator drug (Frisium® 10 mg Tablet produced by PT Aventis Pharma, Indonesia). 
Interventions: Test drug: Clobazam 10 mg Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Frisium® 10 mg Tablet (produced by PT Aventis Pharma, Indonesia) 
INA-M75W610  Complete   Bioequivalence study of Clobazam 10 mg Tablet produced by PT Dexa Medica in comparison with the comparator drug (Frisium® 10 mg Tablet produced by PT Aventis Pharma, Indonesia). 
Interventions: Test drug: Clobazam 10 mg Tablet (produced by PT Dexa Medica, Indonesia) Reference drug: Frisium® 10 mg Tablet (produced by PT Aventis Pharma, Indonesia) 
INA-O853OEX  Complete   Bioequivalence study of sitagliptin/metformin 50 mg/1000 mg extended release tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in comparison with the comparator drug (Janumet® XR 50 mg/1000 mg Extended Release Tablet produced by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico, registered by PT Organon Pharma Indonesia Tbk., Indonesia) . 
Interventions: Test drug: Sitagliptin/Metformin 50 mg/1000 mg Extended Release Tablet (produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals, Indonesia). Reference drug : Janumet® XR 50 mg/1000 mg Extended Release Tablet (produced by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico, registered by PT Organon Pharma Indonesia Tbk., Indonesia). 
INA-YYOOLOW  Complete   Bioequivalence study of Captopril 12.5 mg Tablet produced by PT Dexa Medica in comparison with the comparator drug (Captopril 50 mg Tablet produced by PT Dexa Medica). 
Interventions: Test drug: Captopril 12.5 mg Tablet (produced by PT Dexa Medica, Indonesia) Reference drug Captopril 50 mg Tablet (produced by PT Dexa Medica, Indonesia) 
INA-0PPB91L  Complete   Bioequivalence Study of 1 mg Glimepiride Tablet Manufactured by PT Hexpharm Jaya in Comparison with 1 mg Amaryl® Tablet Manufactured by PT Aventis Indonesia Pharma, Indonesia. 
Interventions: 1 mg Glimepiride Tablet 
INA-9PQMGFP  Initial   CTP-MCVF-006 
Interventions: Menhycia [Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)] (MCV4) 
INA-G4G4Z92  Complete   Bioequivalence study of Azithromycin 500 mg film coated caplets, Zithrotix 500 manufactured by PT IFARS Pharmaceutical Laboratories in comparison Azithromycin 500 mg film coated tablets, Zithromax manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc. New York, U.S.A 
Interventions: Zithrotix 500 (Azithromycin 500 mg) film coated caplets manufactured by PT IFARS Pharmaceutical Laboratories 
INA-6OYHFSL  Complete   Bioequivalence Study of Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets Manufactured by PT. Graha Farma in Comparison with Ciprobay® 500 mg Film-Coated Tablets Manufactured by Bayer AG, Germany, Registered by Bayer (South East Asia) Pte, Ltd, Singapore 
Interventions: Floxigra (Ciprofloxacin 500 mg) Film-Coated Caplets 
INA-DRXBBXT  Complete   Bioequivalence Study of 20 mg Tadalafil Film Coated Tablets Produced by PT Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly del Caribe Inc., Puerto Rico, Packed and Released by Lilly S.A., Spain, Registered by PT Pyridam Farma Tbk., Indonesia 
Interventions:  
INA-7PWPPWH  Complete   Bioequivalence Study of 10 mg Amlodipine Tablet, Manufactured and Registered by PT Prima Medika Laboratories (Gensia® 10 mg) In Comparison with the Innovator’s Tablet (Norvask®) Manufactured by PT Pfizer Indonesia, Jakarta-Indonesia 
Interventions: Single dose of 10 mg Amlodipine Tablet (Gensia® 10 mg), manufactured by PT Prima Medika Laboratories 
INA-HRTY37H  Complete   Bioequivalence Study of 50 mg Diclofenac Sodium Enteric Coated Tablets, Manufactured by PT First Medipharma (Diclofenac Sodium) in Comparison with the Innovator’s Enteric Coated Tablets (Voltaren®), Manufactured by PT Novartis Indonesia, Jakarta, Indonesia 
Interventions: Single dose of 50 mg Diclofenac Sodium Enteric Coated Tablet manufactured by PT First Medipharma 
INA-N3LHAG3  Complete   Bioequivalence Study of 50 mg Diclofenac Sodium Enteric Coated Tablets, Manufactured by PT First Medipharma (Diclofenac Sodium) in Comparison with the Innovator’s Enteric Coated Tablets (Voltaren®), Manufactured by PT Novartis Indonesia, Jakarta, Indonesia 
Interventions: Single dose of 50 mg Diclofenac Sodium Enteric Coated Tablet manufactured by PT First Medipharma 
INA-BWBFS5L  Complete   Bioequivalence study of Amlodipine 10 mg tablet, Konipid® manufactured by PT Konimex in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions:  
INA-ASCGPAR  Complete   Bioequivalence study of New 2 FDC Film-Coated Tablet (Rifampicin 150 mg/Isoniazid 75 mg) produced by PT Phapros Tbk. in comparison with the comparator drug (Rifinah® 300 mg/150 mg Film Coated Tablet of Sanofi S.p.A., Italy) 
Interventions: New 2 FDC Film Coated Tablet produced by PT Phapros Tbk. 
INA-FO28LEM  Complete   Bioequivalence study of Amlodipine 10 mg caplet manufactured by PT Sampharindo Perdana in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg caplet manufactured by PT Sampharindo Perdana 
INA-F6ZC8FP  Complete   Bioequivalence study of amlodipine besylate 10 mg tablet (Ervask Tablet) produced by PT Erlangga Edi Laboratories in comparison with the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one of the test drug (amlodipine 10 mg tablet produced by PT Erlangga Edi Laboratories) or one of the comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia) with 200 mL of water. 
INA-C4ZSA4F  Complete   Bioequivalence Study of Zidalev Film-Coated Caplets (Levofloxacin Hemihydrate Equivalent to Levofloxacin 500 mg) Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Cravit® 500 mg Film-Coated Tablets Manufactured by PT Kalbe Farma Tbk, Bekasi, Indonesia Under License of Daiichi Sankyo Co., Ltd., Tokyo, Japan. 
Interventions: Zidalev film-coated caplets (Levofloxacin hemihydrate equivalent to levofloxacin 500 mg) 
INA-T799STX  Initial   Bioequivalence Study of Moxifloxacin 400 mg Film-Coated Caplets, Quimox manufactured by PT Gracia Pharmindo in comparison with Moxifloxacin 400 mg Film-Coated Tablets, Avelox® manufactured by Bayer AG, Leverkusen - Germany; imported by PT Bayer Indonesia 
Interventions:  
INA-6R5M5DE  Complete   Bioequivalence study of Zevask 10 caplet (Amlodipine Besylate equivalent to Amlodipine 10 mg) manufactured by PT IFARS Pharmaceutical Laboratories in comparison with Norvask® tablet (Amlodipine Besylate equivalent to Amlodipine 10 mg) manufactured by PT Pfizer Indonesia 
Interventions: Zevask caplet (Amlodipine Besylate equivalent to Amlodipine 10 mg) manufactured by PT IFARS Pharmaceutical Laboratories 
INA-C1G6M4F  Complete    Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet manufactured by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories 
INA-NZAXLYO  Complete   Bioequivalence study of atorvastatin 40 mg film coated tablet produced by PT Pratapa Nirmala in comparison with the comparator drug (Lipitor® 40 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects 
Interventions: one atorvastatin 40 mg film coated tablet of test drug (T) given as a single oral dose with 250 mL of water at ambient temperature after an overnight fast of at least 10 hours 
INA-B8YM7YA  Complete   bioequivalence study of Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana in comparison Bisoprolol Fumarate 5 mg film coated tablets, Concor manufactured by PT Merck Tbk, Jakarta, Indonesia; under license by Merck Healthcare KGaA, Darmstadt, Germany 
Interventions: Bisoprolol Fumarate 5 mg film coated tablets manufactured by PT Sampharindo Perdana 
INA-2LMZ27B  Complete   bioequivalence study of Clozapine 25 mg Immediate Release Caplet manufactured by PT Lapi Laboratories in comparison with Clozapine 25 mg Immediate Release Tablet, Clozaril® manufactured by Novartis Saglik, Istanbul, Turkey; imported by Meda Pharma (Thailand) Co., Ltd Bangkok for Thailand 
Interventions: Clozapine 25 mg Immediate Release Caplet Manufactured by PT Lapi Laboratories 
INA-96LF5X2  Complete   Bioequivalence study of Pyrazinamide 500 mg tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Pyrazinamide 500 mg film coated tablet, Pyrafat® manufactured by SW Pharma GmbH for RIEMSER Pharma GmbH, Schiffweiler - Germany 
Interventions: Pyrazinamide 500 mg tablet manufactured by PT Promedrahardjo Farmasi Industri 
INA-PADPAYR  Complete   Bioequivalence study of Azithromycin 500 mg, Azomep® film coated tablets manufactured by PT Meprofarm in comparison with Azithromycin 500 mg, Zithromax® film coated tablets manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc. New York, U.S.A. 
Interventions: Azithromycin 500 mg, Azomep® film coated tablets manufactured by PT Meprofarm 
INA-K0T77QS  Complete   Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT. Bernofarm in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Teva Takeda Pharmaceuticals Co., Ltd., Osaka, Japan. 
Interventions: 30 mg Lansoprazole delayed-release capsule 
INA-SMEH885  Initial   “Uji Efektifitas dan Keamanan Allgeneic Umbilical Cord Derived Mesenchymal Stem Cell(UC-MSC) dan Allogeneic Mesenchymal Stem Cell Derived Exosome pada Terapi Osteoartritis Lutut" 
Interventions: Injeksi lutut 25juta sel punca mesenkimal manusia (MSC) berasal dari Wharton jelly dan 50 juta unit sel eksosom berasal dari MSC 
INA-BGOP68W  Complete   Uji Bioekivalensi Kapsul Siclidon® 100 (Doksisiklin Hiklat Setara Dengan Doksisiklin 100 mg) Produksi PT Caprifarmindo Laboratories Untuk PT Sanbe Farma Dibandingkan Terhadap Kapsul Vibramycin® (Doksisiklin Hiklat Setara Dengan Doksisiklin 100 mg) Produksi Farmasierra Manufacturing SL, Spanyol Dipasarkan Oleh Pfizer Healthcare Ireland, Irlandia Pada Subjek Sehat 
Interventions: Penelitian yang dilakukan adalah penelitian bioekivalensi dosis tunggal. Penelitian dilakukan dengan desain acak, dan menyilang dalam 2 periode (two-way crossover design), dengan kedua perlakuan dipisahkan dengan periode washout, selama 2 minggu dengan keadaan puasa. Penelitian dilakukan dengan menyamarkan obat (blinding). Selama penelitian berlangsung, dilakukan pemantauan terhadap klinis subjek. Pemantauan tersebut meliputi kondisi vital, diet, waktu tidur, dan kegiatan subjek, penggunaan masker, dan physical distancing. Obat uji Kapsul Siclidon® 100 (Doksisiklin Hiklat setara dengan Doksisiklin 100 mg) produksi PT Caprifarmindo Laboratories untuk PT Sanbe Farma dan obat komparator kapsul Vibramycin® (Doksisiklin Hiklat setara dengan Doksisiklin 100 mg) produksi Farmasierra Manufacturing SL, Spanyol dipasarkan oleh Pfizer Healthcare Ireland, Irlandia 
INA-G0W0QCA  Complete   Bioequivalence study of Xaliquis 5 (5 mg Apixaban) film-coated tablet produced by PT Imedco Djaja in comparison with Eliquis (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia. 
Interventions: The reference drug was Eliquis® (5 mg Apixaban) film coated tablet manufactured by Bristol-Myers Squibb Company, packaged and released by Catalent Anagni S.r.l, imported by PT Pfizer Indonesia. The test drug was Xaliquis 5 (5 mg Apixaban) film coated tablet produced by PT Imedco Djaja. In the morning of the sampling as scheduled, subjects were given one dose of Apixaban products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. 
INA-P0R1NFL  Complete   BIOEQUIVALENCE STUDY OF 100 MG SILDENAFIL CITRATE FILM COATED TABLET PRODUCED BY PT CORSA INDUSTRIES IN COMPARISON WITH VIAGRA (100 MG SILDENAFIL CITRATE) FILM COATED TABLET MANUFACTURED BY FAREVA AMBOISE, POCE-SUR-CISSE, PERANCIS IMPORTED BY PT PFIZER INDONESIA 
Interventions: The reference drug was Viagra® (100 mg Sildenafil Citrate) film coated tablet produced by Fareva Amboise, Poce-Sur-Cisse, France, imported by PT Pfizer Indonesia. The test drug was 100 mg Sildenafil Citrate film coated tablet produced by PT Corsa Industries. In the morning of the sampling as scheduled, subjects were given one dose of Sildenafil Citrate products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. 
INA-CDBZ2AM  Complete   Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol) Manufactured by PT. Nufarindo in Comparison with 30 mg Prevacid® Delayed-Release Capsule Manufactured by Takeda Italia S.P.A, Distribution By Takeda Pharmaceuticals America Inc., USA. 
Interventions: 30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol) 
INA-NSEQ28B  Complete   Uji Bioekivalensi Kapsul Lepas Tunda Pumpitor (Omeprazol 20 mg) Produksi PT Caprifarmindo Laboratories Untuk PT Sanbe Farma Dibandingkan Terhadap Kapsul Lepas Tunda Losec 20 mg (Omeprazole 20 mg) Produksi AztraZaneca AB, Swedia Pada Subjek Sehat 
Interventions: Pengujian dilakukan secara komparatif pada subjek sehat dengan desain replicate, dan menyilang dalam waktu 3 periode (partial reference-replicated 3-way crossover design) menggunakan Kapsul Lepas Tunda Losec® 20 mg (Omeprazol 20 mg) (II) sebagai obat komparator dan sampel plasma untuk pengujian 
INA-0RQB3T9  Complete   Bioequivalence study of Candesartan 16 mg tablets manufactured by PT Sampharindo Perdana in comparison Candesartan 16 mg tablets, Blopress® manufactured by PT Takeda Indonesia; Under Licensed by Takeda Pharmaceutical Company Limited, Osaka, Japan 
Interventions: Candesartan 16 mg tablets manufactured by PT Sampharindo Perdana 
INA-2T3OWL2  Recruit   Bioequivalence Study of 200 mg Quetiapine (Quetvell® XR) Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Seroquel XL 200 mg Extended Release Tablets Manufactured by Astrazeneca Pharmaceuticals LP, USA, Packed and Released by Astrazeneca Pharmaceuticals Co. Ltd., China, Imported by Astrazeneca Indonesia. 
Interventions:  
INA-KP6GBKK  Complete   BIOEQUIVALENCE STUDY OF THROMBO ASPILETS (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY PT DARYA-VARIA LABORATORIA TBK IN COMPARISON WITH CARDIO ASPIRIN (100 MG ACETYLSALICYLIC ACID) ENTERIC COATED TABLET PRODUCED BY BAYER PHARMA AG, LEVERKUSEN - GERMANY FOR BAYER CONSUMER CARE AG, SWITZERLAND, IMPORTED BY PT. BAYER INDONESIA 
Interventions: Acetylsalicylic Acid, Administered orally 
INA-SFX8A9Y  Complete   UJI BIOEKIVALENSI KAPSUL NEUROSANTIN® (GABAPENTIN 300 mg) PRODUKSI PT SANBE FARMA DIBANDINGKAN TERHADAP KAPSUL NEURONTIN® (GABAPENTIN 300 mg) PRODUKSI PFIZER PHARMACEUTICALS LLC, PUERTO RICO DIIMPOR OLEH PT PFIZER INDONESIA PADA SUBJEK SEHAT 
Interventions: Pengujian dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Kapsul Neurontin® (II) sebagai obat komparator dan sampel serum untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00 – 07.00 WIB dengan 220 mL air pada suhu ruang. 
INA-825632G  Complete   Bioequivalence Study of 10 mg Amlodipine Besylate Tablets (Intervask) Manufactured by PT Interbat in Comparison with 10 mg Norvask® Tablets Manufactured by PT Pfizer Indonesia. 
Interventions: Intervask 10 mg tablet 
INA-MXAATHZ  Initial   A RANDOMIZED TRIAL COMPARING TREATMENT COMPLETION OF DAILY RIFAPENTINE & ISONIAZID FOR ONE MONTH (1HP) TO WEEKLY RIFAPENTINE & ISONIAZID FOR 3 MONTHS (3HP) IN PERSONS LIVING WITH HIV AND IN HIV-NEGATIVE HOUSEHOLD CONTACTS OF RECENTLY DIAGNOSED TUBERCULOSIS PATIENTS 
Interventions: 1HP (daily isoniazid 300 mg and rifapentine 600 mg for one month/28 days) 
INA-2KM7HAC  Complete   Bioequivalence study of Amlodipine 10 mg tablet, Provask® manufactured by PT Ikapharmindo Putramas in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet, Provask® manufactured by PT Ikapharmindo Putramas 
INA-7E523N8  Complete   Bioequivalence Study of 200 mg Cefixime Hard Gelatin Capsule Produced by PT. Pharos Indonesia (Fixiphar®) In Comparison with the Innovator’s Film Coated Caplet (Cefspan®) 200 mg, Manufactured by PT. Dankos Farma, Jakarta-Indonesia, for PT. Kalbe Farma Tbk., Bekasi-Indonesia, Under License Astellas Pharma Inc., Osaka-Japan 
Interventions: 200 mg Cefixime Hard Gelatin Capsule (Fixiphar®) Manufactured by PT Pharos Indonesia 
INA-C4F4B5D  Complete   Bioequivalence study of Itraconazole 100 mg Capsule, Spyrocon® manufactured by PT Interbat in comparison with Itraconazole 100 mg Capsule, Sporanox® manufactured by Janssen-Cilag S.p.A, via C. Janssen, 
Interventions: Itraconazole 100 mg Capsule, Spyrocon manufactured by PT Interbat 
INA-F0SK3ZE  Complete   Bioequivalence study of Amlodipine Besilate 10 mg Tablet manufactured by PT Bernofarm in comparison with Amlodipine Besilate 10 mg Tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet manufactured by PT Bernofarm 
INA-KR9CX1W  Complete   Bioequivalence Study of 500 mg Levofloxacin Film Coated Tablets (Nislev®), Manufactured by PT. Prima Medika Laboratories, in Comparison with the Innovator’s Film Coated Tablets (Cravit®), Manufactured by PT. Kalbe Farma, Bekasi-Indonesia 
Interventions: Nislev® film-coated tablet, containing 500 mg Levofloxacin, manufactured by PT Prima Medika Laboratories 
INA-987Y1Z  Complete   Uji Bioekivalensi Tablet Salut Selaput Vasotam Plus® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi PT. Pharos Indonesia Dibandingkan dengan Produk Komparator Tablet Salut Selaput Exforge® yang Mengandung Kombinasi Amlodipine 10 mg dan Valsartan 160 mg Produksi Novartis Farmaceutica S.A. Barbera del Valles, Spanyol untuk Novartis Pharma AG, Basel, Swiss yang diimpor oleh PT. Novartis Indonesia, Jakarta, Indonesia 
Interventions: Amlodipine-Valsartan manufactured by the Sponsor 
INA-2SR7KNB  Complete   Bioequivalence study of Atranac 50 (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Corsa Industries in comparison with Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia, under supervision of Novartis Pharma AG. 
Interventions: The reference drug was Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia under supervision of Novartis Pharma AG. The test drug was Atranac 50 (50 mg Diclofenac Sodium enteric coated tablet produced by PT Corsa Industries. In the morning of the sampling as scheduled, subjects was given one dose of Diclofenac Sodium products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. 
INA-4ZHSDTN  Complete   Bioequivalence study of Pitavastatin Calcium 4 mg film coated tablet produced by PT Yarindo Farmatama in comparison with Livalo (4 mg Pitavastatin Calcium) film coated tablet manufactured by Kowa Company, Ltd., imported by PT Mitsubishi Tanabe Pharma Indonesia. 
Interventions: The reference drug was Livalo (4 mg Pitavastatin Calcium) film coated tablet manufactured by Kowa Company, Ltd., imported by PT Mitsubishi Tanabe Pharma Indonesia. The test drug was Pitavastatin Calcium 4 mg film coated tablet produced by PT Yarindo Farmatama. 
INA-6FT5M32  Complete   Bioequivalence study of Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala in comparison with Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc. 
Interventions: The reference drug was Prevacid® (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd., Italy, distributed by Takeda Pharmaceuticals America, Inc. The test drug was Prazotec® (Lansoprazole 30 mg) delayed release capsule produced by PT Pratapa Nirmala. 
INA-YARGR4T  Recruit   Bioequivalence Study of 60 mg Pyridostigmine Bromide Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Mestinon® 60 mg Sugar Coated Tablets Manufactured by Labiana Pharmaceuticals S.L. Spain for A. Menarini Asia-Pacific Holdings Pte. Ltd., Singapore, Imported by PT Menarini Indria Laboratories, Indonesia, Packed and Released by PT Combiphar, Indonesia 
Interventions:  
INA-S8XQN8O  Complete   Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Lapi Laboratories in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of the test drug (clopidogrel 75 mg film-coated tablet produced by PT Lapi Laboratories) or one film-coated tablet of the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France). 
INA-EL4DB2H  Complete   Bioequivalence Study of 2 mg Glimepiride Tablets Manufactured by PT. Interbat (Friladar® 2 Tablet) in Comparison with 2 mg Amaryl® Tablets Manufactured by PT. Aventis Pharma, Indonesia 
Interventions: Glimepiride 2 mg tablets 
INA-3KAWTX6  Complete   Bioequivalence study of dapagliflozin 10 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia). 
Interventions: Test drug: Dapagliflozin 10 mg film-coated tablet produced by PT Dexa Medica Reference drug: Forxiga® 10 mg Film-Coated Tablet manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-NNADLXQ  Complete   Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Kimia Farma Tbk in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg tablet manufactured by PT Kimia Farma Tbk 
INA-S6X7B8F  Complete   bioequivalence study of Azithromycin 500 mg film coated caplets, Zycin 500 manufactured by PT Interbat in comparison Azithromycin 500 mg film coated tablets, Zithromax® manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc. New York, U.S.A 
Interventions: Azithromycin 500 mg film coated caplets, Zycin 500 manufactured by PT Interbat 
INA-7Z21AH4  Initial   PCV13-004 
Interventions: 13-valent Pneumococcal Conjugate Vaccine (PCV13-TT) to Healthy Infants 
INA-PB0FH0X  Complete   Bioequivalence Study of 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin in Compared with 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland 
Interventions: The reference drug was 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland, Batch Number EW4078, Expiry Date June 30th 2024. The test drug was 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin, Batch Number 2211-10-47, Manufacturing Date November 09th 2022, Expiry Date November 2024. In sampling day, subject took one dose of Piroxicam manufactured of either formulation (reference or test) as per randomization scheme with 1 capsule of 20 mg (to be taken with 220 mL of water) in sitting position. 
INA-8978G03  Complete   Bioequivalence study of Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories 
INA-3CMCOZA  Complete   Bioequivalence study of Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Amlodipine 10 mg caplet, Tensiblat® manufactured by PT Harsen Laboratories 
INA-NDZ13R0  Complete   Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Kalbe Farma, Tbk for PT. Hexpharm Jaya in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia. 
Interventions: 300 mg Fenofibrate Capsules 
INA-CANTSHK  Complete   Bioequivalence study of Amlodipine 10 mg tablet, Intervask® manufactured by PT Interbat in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Test Drug : Amlodipine 10 mg tablet, Intervask (BN: ZT0087302) manufactured by PT Interbat 
INA-SKE9T0Y  Complete   Bioequivalence study of Amlodipine 10 mg tablet manufactured by PT Imedco Djaja in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia 
Interventions: Test Drug : Amlodipine 10 mg tablet manufactured by PT Imedco Djaja 
INA-HGL3DDG  Complete   BIOEQUIVALENCE STUDY OF ALZIM (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH ARICEPT EVESS (10 MG DONEPEZIL HYDROCHLORIDE) ORODISPERSIBLE TABLET MANUFACTURED BY BUSHU PHARMACEUTICAL LTD. SAITAMA-KEN, JAPAN, UNDER THE AUTHORITY OF EISAI CO., LTD. TOKYO, JAPAN, IMPORTED BY PT EISAI INDONESIA, BOGOR-INDONESIA 
Interventions: The reference drug was Aricept Evess (10 mg Donepezil Hydrochloride) orodispersible tablet manufactured by Bushu Pharmaceutical Ltd. Saitama-Ken, Japan, under the authority of Eisai Co., Ltd. Tokyo, Japan, imported by PT Eisai Indonesia, Bogor-Indonesia, batch number 06A23P, manufacturing date 25 May 2020; expiration date on 24 May 2023. The test drug was Alzim (10 mg Donepezil Hydrochloride) orodispersible tablet produced by PT Pratapa Nirmala, batch number 1AH042; manufacturing date on August 2022; expiration date on August 2024. 
INA-GD7CTRF  Recruit   Bioequivalence Study of Nospirinal® 80 mg Enteric Coated Tablet Produced by PT. Novell Pharmaceutical Laboratories in Comparison with CardioAspirin® 100 mg Enteric Coated Tablet Manufactured by Bayer Pharma AG, Germany for Bayer Consumer Care AG, Switzerland Imported by PT Bayer Indonesia 
Interventions:  
INA-YAHYY5H  Complete   Bioequivalence Study of 400 mg Moxifloxacin Film Coated Tablets Manufactured by PT. Mega Lifesciences Indonesia (Moximed) In Comparison with the Innovator's Film Coated Tablets (Avelox) Manufactured by Bayer AG, Leverkusen - Germany, Imported and Packaged by PT. Bayer Indonesia, Depok - Indonesia 
Interventions: Bioequivalence Study of 400 mg Moxifloxacin Film Coated Tablets Manufactured by PT. Mega Lifesciences Indonesia (Moximed) In Comparison with the Innovator's Film Coated Tablets (Avelox) Manufactured by Bayer AG, Leverkusen - Germany, Imported and Packaged by PT. Bayer Indonesia, Depok - Indonesia 
INA-WEKBDY6  Complete   Bioequivalence study of Fenofibrate 160 mg film-coated tablet (Fenolip Supra 160) produced by PT Meprofarm in comparison with the comparator drug (Lipanthyl® Supra 160 mg Film-Coated Tablet manufactured by Recipharm Fontaine, France, imported by PT Abbott Indonesia, Indonesia) when administered under high fat meal condition in healthy subjects 
Interventions: The participating subjects were given orally one film-coated tablet of the test drug (Fenolip Supra 160 produced by PT Meprofarm) 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. 
INA-HWNSQBW  Complete   Bioequivalence Study of Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) Manufactured by PT. Interbat in Comparison with Ciproxine® 500 mg Film-Coated Tablets Manufactured by Bayer SA-NV (Machelen). 
Interventions: Ciprofloxacin 500 mg Film-Coated Caplets (Interflox 500) 
INA-772MFT2  Recruit   BIOEQUIVALENCE STUDY OF LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, LAPROTON® MANUFACTURED BY PT TEMPO SCAN PACIFIC TBK IN COMPARISON WITH LANSOPRAZOLE 30 MG DELAYED-RELEASE CAPSULE, PREVACID® MANUFACTURED BY TAKEDA PHARMACEUTICALS AMERICA INC., USA; ENCAPSULATED AND PACKAGED BY ABBOTT LABORATORIES ARGENTINA S.A., ARGENTINA 
Interventions: Laproton® (Lansoprazole 30 mg Delayed-Release Capsule) manufactured by PT Tempo Scan Pacific Tbk. 
INA-LQDX9N2  Complete  
Interventions: All subjects fasted at least 10 hours during the night prior to the drug administration. On 29th August 2016 (± 06.30 AM) subjects were instructed to consume one piece of meat bread. At 07.00 AM subjects were instructed to consume one film coated caplet of test or one film coated tablet of reference product with 240 mL of water. Subjects were given 100 ml of 10% glucose solution per hour for the first four hours after drugs administration to avoid hypoglycemia. No food intake was allowed until 4 hours after drug administration. Water intake was allowed ad libitum one hour before dosing and 2 hours thereafter. Standardized meals were served at 4, 8, and 12 hours after medication. 
INA-DMA8KOH  Complete   Bioequivalence Study of 500 mg Azithromycin Film Coated Caplets, Manufactured by PT. Prima Medika Laboratories (Aztrin®), Registered by PT. Pharos Indonesia in Comparison with the Innovator’s Film Coated Tablets (Zithromax®), Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, Under Supervision of Pfizer Inc. New York, N.Y., U.S.A. 
Interventions: All subjects were fasted start from 09.00 p.m. to drug administration. On the next day, physician instructed subjects to consume 1 film coated caplet of test product or 1 film coated tablet product with 240 mL of water or equivalent to a glass of mineral water. Before given to subjects, test or reference drug was mixed completely. Investigator were onsite to ensure that each subject swallows the study products. Physician ensured that each subject swallowed the study products. 
INA-561T56Q  Complete   Bioequivalence study of Etoricoxib 120 mg Film-Coated Tablet, Ricoxa manufactured by PT Interbat in comparison with Etoricoxib 120 mg Film-Coated Tablet, Arcoxia TM manufactured by Rovi Pharma Industrial Services S.A., Madrid, Spain; registered and packed by PT Merck Sharp Dohme Pharma Tbk, Pasuruan, East Java. 
Interventions: the test drug Ricoxa (BN: ZT1587201) manufactured by PT Interbat 
INA-AW77WRS  Complete   Bioequivalence Study of 0.5 mg Entecavir Film-Coated Tablet Manufactured by PT. Kalbe Farma, Tbk. for PT. Hexpharm Jaya in Comparison with 0.5 mg Baraclude® Film-Coated Tablet Manufactured by AstraZeneca Pharmaceuticals LP, Indiana, USA and Marketed by Bristol-Myers Squibb, Singapore 
Interventions: 0.5 mg Entecavir Film-Coated Tablet 
INA-ROT77EZ  Complete   Bioequivalence Study of Azithromycin 500 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk Compared to Zithromax® 500 mg Film-Coated Tablets Manufactured by PT. Pfizer Indonesia 
Interventions: The reference drug was Zithromax® 500 mg Film-Coated Tablets produced by PT. Pfizer Indonesia, batch number A200168, manufacturing date on September 2020, expired date on August 2024. The test drug was Azithromycin 500 mg fil-coated Tablet produced by PT Kimia Farma Tbk, batch number J03K2403, manufacturing date November 2022, Expired date October 2024. On the sampling day, the subject took one dose of azithromycin manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in a seated position. 
INA-9F4KMB3  Complete   Bioequivalence Study of Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries Compared to Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc. 
Interventions: The reference drug was Prevacid® 30 mg Produced by Takeda Pharmaceutical U.S.A., Inc, batch number 21119QA, manufacturing date on March 2020, expired date on February 2023. The test drug was Lansoprazole 30 mg Capsule Produced by PT. Novapharin Pharmaceutical Industries, batch number 2107-01-273A, manufacturing date July 2021, Expired date July 2023. In sampling day, subject took one dose of Lansoprazole manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-P8L1SBH  Complete   Bioequivalence study of montelukast 10 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Singulair® 10 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., United Kingdom, packed and registered by PT Merck Sharp Dohme Pharma Tbk., Indonesia) 
Interventions: Test drug: Montelukast 10 mg film-coated tablet produced by PT Dexa Medica Reference drug: Singulair® 10 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., United Kingdom, packed and registered by PT Merck Sharp Dohme Pharma Tbk., Indonesia The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-F8CA5QT  Complete   Bioequivalence study of Telmisartan 80 mg caplet manufactured by PT Lapi Laboratories in comparison with Telmisartan 80 mg, Micardis tablet manufacutred by Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein, Germany; for Boehringer Ingelheim Pharma GmbH, Ingelhaim am Rhein, Germany; imported by PT Boehringer Ingelheim Indonesia 
Interventions: Telmisartan 
INA-YDX6W84  Complete   Bioequivalence study of azithromycin 500 mg film-coated caplet produced by PT Erlimpex in comparison with the comparator drug (Zithromax® 500 mg Film-Coated Tablet, PT Pfizer Indonesia, under supervision of Pfizer Inc. New York, N.Y., U.S.A) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (azithromycin 500 mg film coated caplet produced by PT Erlimpex) 
INA-PWM9RR5  Complete   Bioequivalence Study of Bisoprolol Fumarate 10 mg Film-Coated Tablets Manufactured by PT. Lapi Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Tbk, Jakarta, Indonesia Under License from Merck Healthcare KGaA, Darmstadt, Germany. 
Interventions: Bisoprolol Fumarate 10 mg Film-Coated Tablets 
INA-5WPGEH3  Complete   Bioequivalence Study of Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia 
Interventions: The reference drug was Ventolin® 2x2 mg Tablet Produced by PT. Glaxo Wellcome Indonesia, batch number 424T, manufacturing date on December 2019, expired date on November 2021. The test drug was Salbutamol 4 mg Tablet Produced PT. Kimia Farma Tbk, batch number A00035NX, manufacturing date January 2020, Expired date January 2022. In sampling day, subject took one dose of Salbutamol manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-NC9AN58  Complete   Bioequivalence Study of Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk. Compared to Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia 
Interventions: The reference drug was Movi-Cox® 15 mg Tablet Produced by PT. Boehringer Ingelheim Indonesia, batch number 19020306, manufacturing date on March 2019, expired date on February 2022. The test drug was Meloxicam 15 mg Tablet Produced PT. Kimia Farma Tbk, batch number FP09.E2004.021, manufacturing date May 2020, Expired date April 2022. In sampling day, subject took one dose of Meloxicam manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-TWPETGQ  Complete   Bioequivalence Study of Favipirafir 200 mg Film Coated Tablets Produced by PT. Kimia Farma Tbk Compared to Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd 
Interventions: The reference drug was Avigan® 200 mg Film Coated Tablets Produced by Fujifilm Toyama Chemical Co., Ltd, batch number HG2101A, expired date on Juli 2023. The test drug was Favipiravir 200 mg Tablet produced by PT Kimia Farma Tbk, batch number G10110N, manufacturing date July 27th 20221 Expired date July 27th 2022. In sampling day, subject took one dose of Favipiravir manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-MKKRG0A  Complete   Bioequivalence study of Fixed Dose Combination of Levodopa 100 mg and Benserazide 25 mg, Levoben Tablet manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Levodopa 100 and Benserazide 25 mg, Madopar Tablets Distributed in Australia by Roche Products Pty Limited, Level 8, 30-34 Hickson Road Sydney NSW 2000 
Interventions: Not applicable 
INA-48CBPT0  Complete   Bioequivalence Study of Carvedilol 25 mg Tablets Manufactured by PT. Kalbe Farma Tbk in Comparison with Dilatrend® 25 mg Tablets Manufactured by Delpharm Milano S.r.l., Via Varnevale, Segrate (MI), Italy under license of Cheplapharm Arzneimittel GmbH, Greifswald, Germany, Imported by DKSH Malaysia Sdn Bhd, Selangor Darul Ehsan, Malaysia. 
Interventions: Carvedilol 25 mg Tablet 
INA-WTCHL5E  Complete   Bioequivalence Study of Diclofenac Sodium 50 mg Enteric Coated Tablet, Volten Manufactured By PT Promedrahardjo Farmasi Industri In Comparison With of Diclofenac Sodium 50 mg Enteric Coated Tablet, Voltaren Manufactured By Novartis Indonesia 
Interventions:
INA-PCY0S1F  Complete   Bioequivalence Study of Diclofenac Sodium 50 mg Enteric Coated Tablet, Volten Manufactured By PT Promedrahardjo Farmasi Industri In Comparison With of Diclofenac Sodium 50 mg Enteric Coated Tablet, Voltaren Manufactured By Novartis Indonesia 
Interventions:  
INA-7L3LXOM  Complete   Bioequivalence Study of Zidovudine 100 mg Capsules Produced by Pt Kimia Farma Tbk Compared To Retrovir 100 mg Capsules Produced by Glaxosmithkline Pharmaceuticals S.A 
Interventions: The reference drug was Retrovir 100 mg capsules produced by Glaxosmithkline Pharmaceuticals S.A, batch number JN8K, expired date on November 2024. The test drug was Zidovudine 100 mg capsules produced by PT Kimia Farma Tbk, batch number G2 1346 J, manufacturing date July 2022, Expired date July 2025. In sampling day, subject took one dose of Zidovudine manufactured of either formulation (reference or test) as per randomization scheme with 250 mL water in lying position. 
INA-9XN6Q6C  Complete   Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablet Produced by PT Kimia Farma Tbk Compared To Arcoxia 120 mg Film-Coated Tablet Produced by Rovi Pharma Industrial Service 
Interventions: The reference drug was Etoricoxib 120 mg Film-Coated Tablet produced by VIRDEV INTERMEDIATES PVT LTD, batch number FP-ETO-015-21, manufacturing date on september 2021, expired date on August 2026. The test drug was Etoricoxib 120 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number FP04.I2212.048, manufacturing date September 12th 2022, Expired date September 2024. In sampling day, subject took one dose of Etoricoxib manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-Q5PS1FG  Complete   Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Kimia Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, Jiangsu, China, Imported by PT. AstraZeneca Indonesia, Bekasi, Indonesia. 
Interventions: Ticagrelor 90 mg Film-Coated Tablets 
INA-CFZXO98  Complete   Bioequivalence Study of Amlodipine 10 mg Tablet Produced by PT. Kimia Farma Tbk Compared to Norvask® 10 mg Tablet Produced by PT. Pfizer Indonesia 
Interventions: The reference drug was Norvask® 10 mg Tablet produced PT. Pfizer Indonesia, batch number FP9902, manufacturing date on December 2022, expired date on January 2024. The test drug was Amlodipine 10 mg Tablet produced by PT Kimia Farma Tbk, batch number B10L2445, manufacturing date December 22th 2022, Expired date December 22th 2024. In sampling day, subject took one dose of Amlodipine manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-S6DZ56G  Complete   Bioequivalence Study of 500 mg Ciprofloxacin Film Coated Tablet Produced by PT. Hexpharm Jaya in comparison with 500 mg Ciproxin Film Coated Tablet Produced by PT. Bayer Indonesia 
Interventions: Ciprofloxacin 500 mg film coated tablet 
INA-M9SADDB  Complete   Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc 
Interventions: The reference drug was Myambutol Film-Coated Tablet 400 mg produced by Pantheon Inc, Ontario, Canada, for STI Pharma Llc, batch number CFKFD, expired date on November 2023. The test drug was Ethambutol 400 mg Film-Coated Tablet produced by PT Kimia Farma Tbk, batch number J20113NX, Expired date October 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-R1L9TCM  Complete   Bioequivalence Study of Ethambutol 400 mg Entericcoated Tablet Manufactured by PT. Kimia Farma Tbk Compared to Myambutol 400 mg Film-Coated Tablet Manufactured by Pantheon Inc, Ontario, Canada, for STI Pharma Llc 
Interventions: The reference drug was Myambutol Film-Coated Tablet 400 mg produced by Pantheon Inc, Ontario, Canada for STI Pharma Llc, batch number CFKFD, expired date on November 2023. The test drug was Ethambutol 400 mg Tablet produced by PT Kimia Farma Tbk, batch number J20113NX, Expired date October 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-R19L03X  Complete   Bioequivalence Study of 100 mg/5 mL Cefixime Dry Syrup, Manufactured by PT. Pharos Indonesia (Fixiphar®) in Comparison with the Innovator’s Dry Suspension (Suprax®), Manufactured by Odan Laboratories Ltd., Montreal 
Interventions: Subject would be fasted during 10 hours and the next morning, physician instructed subjects to consume 10 mL dry syrup of test product or 10 mL dry suspension product with 240 mL of water or equivalent to a glass of mineral water. The drugs was given with catheter tip, before given to subjects, test or reference drug was mixed completely, then washing the catheter tip. Subjct would be instructed to kept sitting or laying on their back rigt after dosing until four (4) hours after dosing. 
     
Interventions:  
INA-S4PZPOG  Complete   Bioequivalence Study of Simvastatin 20 mg Tablets Produced by PT. Kimia Farma Tbk Compared to Zocor 20 mg Tablets Produced by Merck Sharp & Dohme Ltd. United Kingdom 
Interventions: The reference drug was Zocor® Tablet 20 mg produced by Merck Sharp & Dohme Ltd United Kingdom, batch number W004945, manufacturing date on November 24th 2021, expired date on November 24th 2023. The test drug was Simvastatin 20 mg Tablet produced by PT Kimia Farma Tbk, batch number G20073NX, manufacturing date July 2022, Expired date July 2024. In sampling day, subject took one dose of Simvastatin manufactured of either formulation (reference or test) as per randomization scheme with 250 ml water in lying position. 
INA-KMFN90P  Complete   Bioequivalence Study of Isoniazid 300 mg Tablet Produced by PT Kimia Farma Tbk Compared to Isoniazid 3x100 mg Tablet Produced by Reimser Pharma GMBH 
Interventions: The reference drug was Isozid® (Isoniazid 100 mg) tablet manufactured by: Riemser Pharma GmbH An der Wlek 7-17493 Greifswald-Insel Riems, batch number 001060, expired date on May 2025. The test drug was Isoniazid 300 mg tablet manufactured by PT. Kimia Farma Tbk, batch number I20102NX, manufacturing date 14 October 2022, Expired date 13 October 2024. On the sampling day, the subject took one dose of Isoniazid manufactured of either formulation (reference or test) as per the randomization scheme with 220 ml water in sit position. 
INA-LXQT46H  Complete   Bioequivalence Study of Imatinib Mesylate 400 mg Film-Coated Tablets Manufactured by PT Global Onkolab Farma in Comparison with Glivec® 400 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein A.G., Stein, Switzerland, Imported by PT. Novartis Indonesia. 
Interventions:  
INA-K9B06PS  Initial   Immunogenicity & Safety of IndoVac® as a Homologous Booster Dose Against COVID-19 in Adults Aged 18 Years and Above in Indonesia 
Interventions: IndoVac® Vaccine 
INA-H1QP4AA  Complete   BIOEQUIVALENCE STUDY OF ISONIAZID 300 MG TABLET PRODUCED BY PT. KIMIA FARMA Tbk COMPARED TO ISOZID 3x100 MG TABLET PRODUCED BY REIMSER PHARMA GMBH 
Interventions: Isoniazid 300 mg 
INA-5RDZ7DQ  Complete   Uji Bioekivalensi Santorvastin® 40 FCT (Atorvastatin 40 mg) Produksi PT Sanbe Farma dibandingkan terhadap Lipitor® 40 FCT (Atorvastatin 40 mg) Produksi Pfizer Pharmaceuticals LLC, Puerto Rico, Amerika Serikat diimpor oleh PT Pfizer Indonesia pada Subjek Sehat 
Interventions: Pengujian ketersediaan hayati Atorvastatin dari Santorvastin® 40 FCT yang diproduksi PT. Sanbe Farma telah dilakukan secara komparatif pada subjek sehat dengan desain replicate, dan menyilang dalam waktu 3 periode (partial reference-replicated 3-way crossover design) menggunakan Lipitor® 40 FCT (II) sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air pada suhu ruang. 
INA-YZT2WW5  Complete   Bioequivalence study of celecoxib 200 mg capsule (Celedip® 200) manufactured by PT Dipa Pharmalab Intersains in comparison with the comparator drug (Celebrex® 200 mg capsule manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, imported and packed by PT Pfizer Indonesia, Indonesia) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one capsule of the test drug (Celedip® 200 mg capsule manufactured by PT Dipa Pharmalab Intersains) or one capsule of the comparator drug (Celebrex® 200 mg Capsule, manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, imported and packed by PT Pfizer Indonesia, Indonesia) 
INA-F4516R0  Complete   Bioavailability/bioequivalence study of Risperidone 1 mg Film Coated Caplets manufactured by PT. Bernofarm, Indonesia in comparison with Risperidone 1 mg, Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy. 
Interventions: The test drug was the market available Risperidone 1 mg Film Coated Caplets manufactured by PT Bernofarm, Indonesia; batch number : RST2-19-001E; Manufacturing date : January 17th, 2019; Expired date : January, 2021. The reference drug was the market available Risperidal® Tablets manufactured by Janssen-Cilag S.p.A., Italy; batch number : IJL4600; Expired date : September 2021. In sampling day, Subjects took one dose of Risperidone products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position. The subjects blood samples was taken at a certain times. 
INA-M54GD71  Complete   Bioequivalence study of linezolid 600 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Zyvox® 600 mg Film-Coated Tablet manufactured by Pfizer Pharmaceuticals LLC, Puerto Rico, imported by PT Pfizer Indonesia, Indonesia) 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (linezolid 600 mg film-coated tablet produced by PT Kimia Farma Tbk.) or one comparator drug (Zyvox® 600 mg Film-Coated Tablet manufactured by Pfizer Pharmaceuticals LLC, Puerto Rico, imported by PT Pfizer Indonesia, Indonesia). 
INA-DXW27DE  Complete   Bioequivalence study of molnupiravir 200 mg capsule produced by PT Kimia Farma Tbk. in comparison with the comparator drug Lagevrio® (Molnupiravir 200 mg Capsule manufactured by Merck Sharp Dohme) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were required to have an 8 hours overnight fast and in the next morning (first day of period) were given orally one capsule of the test drug (Molnupiravir 200 mg Capsule produced by PT Kimia Farma Tbk.) or one capsule of the comparator drug (Lagevrio® 200 mg Capsule manufactured by Merck Sharp Dohme) with total 240 mL of water. 
INA-R9L00H7  Complete   Bioavailability/bioequivalence study of 150 mg Pregabalin Capsules: (Pregabalin 150 mg Kapsul) manufactured by PT Bernofarm in comparison with Pregabalin 150 mg, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia. 
Interventions: The test drug was the market available Pregabalin 150 mg capsules manufactured by PT Bernofarm, Indonesia; batch number : RSK-19-034D; Manufacturing date : September 2019; Expired date : September 2021. The reference drug was the market available Pregabalin 150 mg capsules, Lyrica® manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg Germany; imported by PT Pfizer, Indonesia.; batch number : AK5479; Expired date : September 2021. In sampling day, Subjects took one dose of Pregabalin 150 mg capsules products of either formulation (Reference or Test) after an overnight fasted. As randomization scheme with 240 mL of water in sitting position. The subjects blood samples was taken at a certain times 
INA-AF8LWCX  Complete   Bioequivalence study of 300 mg Irbesartan film-coated tablet manufactured by PT Bernofarm in comparison with 300 mg Aprovel® film-coated tablet manufactured by Sanofi Winthrop Industrie, France ; under license by Sanofi Clir SNC, France; imported by PT Aventis Pharma, Jakarta, Indonesia 
Interventions: The test drug was the market available Irbesartan 300 mg film-coated tablet manufactured by PT Bernofarm, Indonesia; batch number : RST2-20-025B; Manufacturing date : November 11th, 2020; Expired date : November 11th, 2022. 
INA-MC6YMFP  Complete   Uji Bioekivalensi Forbetes® 850 FCT (Metformin HCl 850 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Glucophage® 850 MG fct (Metformin HCl 850 mg) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante SAS, Perancis pada Subjek Sehat. 
Interventions: Pengujian ketersediaan hayati metformin dari Forbetes® 850 FCT (I) yang diproduksi PT Sanbe Farma, Indonesia dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Glucophage® 850 mg FCT (II) produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante SAS, Perancis sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air mineral pada suhu ruang. Subjek diberikan larutan glukosa 10% sebanyak 100 mL setiap jam sampai dengan jam ke-3 setelah pemberian obat. 
INA-EXARW07  Initial   Precision Health Care Program on HbA1c and Diabetes Self-management 
Interventions: In this study, the strategies of tailored care for diabetes were divided into 7 steps: (1) Brief deducting teaching; (2) Assessment for self-management level; (3) Brainstorming among patients to share their difficulty on glycaemic target and specific target behaviour; (4) Making a list of patients’ needs then ranking the priorities; (5) Setting a goal and writing action; (6) Follow-up; and (7) Report of goals attempt. Following a brief deducting teaching, two research assistants were involved in delivering the support group and brainstorming. Table 1 shows the specifics tailored care strategies. 
INA-3YBZ2EN  Complete   Bioequivalence Study of Sildenafil Film Coated Tablets 100 mg Produced by PT. Kimia Farma Tbk. Compared to Viagra 100 mg Film-Coated Tablets Produced by Pfizer 
Interventions: The reference drug was Viagra (100 mg Sildenafil) film-coated tablet manufactured by Pfizer batch number B568310, manufacturing date October 2020; expiration date on September 2023. The test drug was Sildenafil (100 mg Sildenafil) film-coated tablet produced by PT Kimia Farma Tbk, batch number FP03.L2129.088; manufacturing date on 29 December 2021; expiration date on 29 December 2023. Subjects were given one dose (1 tablet) of Sildenafil products of either formulation (reference or test), as per randomization scheme with 220 mL of water in a sitting position. 
INA-WRENB65  Complete   Impacts of Moderate Aerobic Exercise on Adiponectin and Pancreatic β-cell Function in Males with Type 2 Diabetes : a Randomized Controlled Trial 
Interventions: Kelompok uji coba menjalani program latihan aerobik yang diawasi selama 4 minggu dengan intensitas sedang, dengan durasi 30 menit per sesi dan frekuensi 3 sesi per minggu. Tekanan darah, detak jantung, dan saturasi oksigen diukur sebelum dan sesudah setiap sesi. Pengambilan sampel darah 30 menit sebelum latihan dan setelah sesi terakhir. Pengukuran glukosa darah 
INA-QLM2BQB  Complete   Bioequivalence Study of 40 mg Furosemide Tablets Manufactured by PT. Bernofarm in Comparison with 40 mg Lasix® Tablets Manufactured by PT. Aventis Pharma, Indonesia. 
Interventions: subjects were given a single dose of 40 mg Furosemide of test drug or of reference drug with 240 mL of water. Subjects were administered the drug products in sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. The subjects should remain in a comfortable recumbent position for up to 8 hours after dosing and remain under medical surveillance for up to 12 hours after dosing. Before they were allowed to ambulate, they should sit up with legs in a dependent position for one minute prior to standing up. While standing immobile, they should be closely observed for blood pressure changes and/or orthostatic symptoms, including nausea, dizziness, or faintness for at least three minutes. 
INA-RPZATFB  Complete   Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Kalbe Farma Tbk for PT. Dankos Farma 
Interventions: Subjects were given a single dose of 500 mg deferasirox of either formulation (test or reference) with 240 ml of water. Tablets should not be chewed or swallowed whole. The drug was completely dispersed by stirring in a glass of water (100 to 200 ml) until a fine suspension was obtained. Subjects administered the suspension in sitting posture. After swallowing the suspension, any residue were re-suspended in the remaining water, and swallowed all. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. 
INA-PY9YS39  Complete   BIOEQUIVALENCE STUDY OF SPIRONOLACTONE 100 MG FILM-COATED TABLET PRODUCED BY PT DEXA MEDICA IN COMPARISON WITH THE COMPARATOR DRUG (ALDACTONE® 100 MG FILM-COATED TABLET, MANUFACTURED BY PFIZER AUSTRALIA PTY LTD, AUSTRALIA) 
Interventions: Spironolactone 100 mg produced by Dexa Medica, Batch no A-18138-01-F-PSC-11 
INA-KDMFZ3  Complete   Bioequivalence study of Aripiprazole 10 mg, Arinia - 10 Tablets manufactured by PT Meprofarm Pharmaceutical Industries in comparison with Aripiprazole 10 mg, Abilify® 10 Tablets manufactured by Korea Otsuka Pharmaceutical Co. Ltd., Korea. Imported By PT Otsuka Indonesia. 
Interventions: The test drug was Arinia (Aripiprazole 10 mg) tablet manufactured by Meprofarm, batch number R0K141, manufacturing date October 2020, Expired date October 2022. 
  Complete   Uji Bioekivalensi Forbetes® 500 FCT (Metformin HCl 500 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Glucophage® 500 mg FCT (Metformin HCl 500 mg) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante Sas, Perancis pada Subjek Sehat 
Interventions: Pengujian ketersediaan hayati metformin dari Forbetes® 500 FCT (I) yang diproduksi PT Sanbe Farma dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Glucophage® 500 mg FCT (II) Produksi PT Merck Tbk., Indonesia di Bawah Lisensi Merck Sante Sas, Perancis sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air mineral pada suhu ruang. Subjek diberikan larutan glukosa 10% sebanyak 100 mL setiap jam sampai dengan jam ke-3 setelah pemberian obat. 
  Recruit   UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study) 
Interventions: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg. One dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride. 
  Complete   Bioequivalence Study of 100 mg Ericfil ® Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Viagra ® 100 mg Film Coated Tablets Produced by Pfizer, France 
Interventions: The reference drug was VIAGRA ® film-coated tablets (100 mg Sildenafil), Lot Number A325402B; Manufacturing date unknown; Expiry date February 2018; manufactured by Pfizer, France. The test drug was Ericfil ® film-coated tablets (100 mg Sildenafil), Batch Number 18L245; Manufacturing date November 2016; Expired Date November 2018; produced by PT Novell Pharmaceutical Laboratories. Each subject received a single oral dose of one FC tablet of 100 mg Ericfil® or Viagra® after an overnight fast for at least 10 hours. The dose was taken at ± 07.00 am with 240 ml of water. Water intake was allowed one hour before and one hour after the dose. 
  Complete   Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT. Lloyd Pharma Indonesia (Coxiloid 120 mg) in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by Rovi Pharma Industrial Services S.A., Spain, registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia. 
Interventions: Subjects were given a single dose of etoricoxib 120 mg of either formulation (test or reference) with 240 mL of water. Subjects were taken the drug products in sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing 
  Complete   Uji Klinis Vaksin Monovalent SARS-CoV-2 mRNA Varian Omicron BA.4/5 
Interventions: Vaksin Uji: SARS-CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020) Plasebo: Physiological Saline Injection 
  Complete   Uji Klinis Vaksin Monovalent SARS-CoV-2 mRNA Varian Omicron BA1 dan Delta 
Interventions: Omicron Vaccine: ABO1009-DP Delta Vaccine: ABO-CoV.617.2 Placebo: Normal saline 
INA-KOE6FKH  Complete   Bioequivalence study of Miozidine MR (35 mg Trimetazidine) film-coated tablet produced by PT Pratapa Nirmala in comparison with Trizedon MR (35 mg Trimetazidine) film-coated tablet manufactured by PT Darya-Varia Laboratoria Tbk, under license of Servier-France. 
Interventions: The reference drug was Trizedon® MR (35 mg Trimetazidine) film coated tablet manufactured by PT Darya-Varia Laboratoria Tbk, under license of Servier-France, batch number MX1A063, manufacturing date December 2021; expiration date on December 2024. The test drug was Miozidine MR (35 mg Trimetazidine) film coated tablet produced by PT Pratapa Nirmala, batch number 1AJ062; manufacturing date on October 2022; expiration date on October 2024. Subjects were given one dose of Trimetazidine products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. 
  Complete   BIOEQUIVALENCE STUDY OF GLUDITIN (100 MG SITAGLIPTIN) FILM COATED TABLET PRODUCED BY PT KONIMEX IN COMPARISON WITH JANUVIA (100 MG SITAGLIPTIN) TABLET PRODUCED BY MERCK SHARP & DOHME LTD., ENGLAND IMPORTED BY PT MERCK SHARP DOHME PHARMA TBK. INDONESIA 
Interventions: This study will assess the bioequivalence of Gluditin (100 mg Sitagliptin Phosphate) film coated tablet produced by PT Konimex in comparison with Januvia® (100 mg Sitagliptin Phosphate) tablet produced by Merck Sharp & Dohme Ltd. Cramlington, England, imported by PT Merck Sharp Dohme Pharma Tbk. 
  Complete   Bioequivalence Study of 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia. 
Interventions: The reference drug was the market available Abbotic® XL 500 mg Modified Release Film Coated Tablets (Produced by PT. Abbot Indonesia) batch number 28724XP; manufacturing date Mei 2021; expiration date Mei 2023. The test drug was Clarithromycin XR Extended Release Film Coated Tablets produced by PT Novell Pharmaceutical Laboratories, batch number D21I04 manufacturing date Oktober 2021; expiration date September 2023. In the sampling day, each subject received a single oral dose of 500 mg Clarithromycin, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. 
INA-H99SEE8  Complete   Bioequivalence study of Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala in comparison with Plavix® (75 mg Clopidogrel) film coated tablet manufactured by PT Aventis Pharma, Indonesia under license of Sanofi Clir SNC, France. 
Interventions: The reference drug was Plavix® (75 mg Clopidogrel) film coated tablet manufactured by PT Aventis Pharma, Indonesia under license of Sanofi Clir SNC, France, batch number 2DN061, manufacturing date December 2020; expiration date on November 2023. The test drug 1 was Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala, batch number 1AH149; manufacturing date on August 2022; expiration date on August 2024. The test drug 2 was Clopidogrel 75 mg film coated tablet produced by PT Pratapa Nirmala, batch number 1AI001; manufacturing date on September 2022; expiration date on September 2024. Subject took one dose of Clopidogrel products (tests or reference), as per randomizaton scheme with 240 mL of water in sitting position. 
INA-CPE6Y84  Complete   Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects 
Interventions: Test drug Clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica Reference drug: Plavix® 75 mg Film-Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-NLTZSWG  Complete   Bioequivalence Study of Cefixime 100 mg Capsule Produced by PT. Pharma Laboratories in Comparison with Cefspan® (100 mg Cefixime) Capsule Manufactured by PT. Dankos Farma, for PT. Kalbe Farma Tbk., under License of Astellas Pharma Inc. 
Interventions: NA 
INA-0E8MRMC  Complete   Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Catur Dakwah Crane Farmasi for PT. Pharma Laboratories in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia, Indonesia 
Interventions: NA 
INA-FW91Q3G  Complete   Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries. 
Interventions: Subjects were given a single dose of 80 mg Febuxostat of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain an upright position (standing or sitting) for 1 hour after dosing. 
INA-EMAMLXK  Complete   Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsule Manufactured by PT. Bernofarm in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Sweden, Imported by AstraZeneca, Indonesia 
Interventions: Subjects were given a single dose of 1 tablet of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. 
INA-3TBDPZ1  Complete   Home-Based Foot-Ankle Exercise Efektif Meningkatkan Ankle Brachial Index Pada Pasien Diabetes Mellitus Tipe 2: Randomized Controlled Trial 
Interventions: Responden dibagi menjadi 2 kelompok yaitu kelompok intervensi dan kontrolRandomisasi dilakukan oleh peneliti dengan menggunakan randomisasi blok. Randomisasi dilakukan oleh orang yang independen dari tim peneliti untuk memastikan peneliti dan peserta tidak mengetahui alokasi. Jumlah subjek dibagi 2 sama besar, dimana dalam 1 blok terdapat 4 subjek sehingga terdapat 6 variasi blok. Peserta secara acak dimasukan kedalam grup menggunakan tabel blok (angka) yang dihasilkan dengan bantuan komputer. Nomor acak yang dihasilkan komputer kemudian ditempatkan dalam amplop buram tersembunyi dan diberikan berdasarkan nomor urut kedatangan responden. Responden tidak mengetahui apakah mereka masuk kedalam kelompok intervensi atau kelompok kontrol Peneliti melibatkan 2 orang peneliti pendamping yang sudah memiliki sertifikat GCP (Good Clinical Practice). Peneliti pendamping bertugas membantu peneliti utama untuk melatih, mengawasi dan melakukan kunjungan rumah serta melakukan observasi pelaksanaan Home- Based Foot–Ankle Exercise pada kelompok intervensi dan senam kaki diabetes pada kelompok kontrol. Tingkat persamaan persepsi antara peneliti dan asisten peneliti mengenai pelaksanaan Home- Based Foot–Ankle Exercise dan latihan senam kaki diabetes telah dilakukan uji kesepakatan dengan menggunakan metode interpreter reliability yaitu dengan uji Kappa. Hasil pengujian analisis dengan menggunakan uji kappa pada asisten penelitian 1 diperoleh hasil nilai kofisien kappa 0,794 (>0,6) dan hasil nilai kofisien kappa antara peneliti utama dan asisten penelitian 2 yaitu 0,659 (>0,6). Pada kedua kelompok Peneliti dan asisten peneliti melakukan pemeriksaan gula darah 2 kali seminggu sebelum latihan atau apabila terdapat tanda & gejala hipoglikemi pada pasien (edukasi diberikan diawal tentang tanda dan gejala hipoglikemi, pencegahan dan penanganan) Pada kedua kelompok 1 jam sebelum latihan, responden diinstruksikan untuk makan (mencegah hipoglikemi) Sehari sebelum intervensi yang pertama dilakukan pengukuran ABI pada kelompok intervensi dan kontrol (pretest) Pada kelompok intervensi diberikan perlakuan Home Based Foot–Ankle Exercise yang terdiri dari 4 kategori gerakan yang dibagi menjadi 10 jenis gerakan yaitu Foot ankle stretching exercises & Ankle Range of Motion terdiri dari gerakan Heel Cord Stretch, Heel Cord Stretch with Bent Knee dan Ankle Range of Motion; Foot ankle strengthening exercises terdiri dari gerakan Golf Ball Roll, Calf Raises, Marble Pickup dan Towel Scrunch; Foot ankle resistance exercises terdiri dari gerakan Calf stretching/ Towel Stretch dan Resistive Exercises with Theraband; serta Balance exercises terdiri dari gerakan Balance Disc. Pada kelompok kontrol diberikan perlakuan senam kaki diabetes yang terdiri dari 7 gerakan. Perlakuan pada kelompok intervensi dan kontrol dilakukan 5 kali dalam seminggu (satu kali perhari) selama 24 kali pertemuan. Sebelum dilakukan intervensi pada kedua kelompok, responden dilakukan pengukuran gula darah sewaktu. Responden yang memiliki kadar gula darah < 100 mg/dL, maka akan ditunda latihan dan diberikan terapi hipoglikemi. Peneliti dan asisten peneliti melakukan pengawasan pelaksanaan Home- Based Foot–Ankle Exercise (pada kelompok intervensi) dan senam kaki diabetes (pada kelompok kontrol) dengan cara melakukan kunjungan ke rumah responden sebanyak dua kali seminggu dan pengawasan menggunakan panggilan video (video call) yang didampingi oleh satu orang anggota keluarga sebanyak tiga kali seminggu Postetest dilakukan keesokan harinya setelah intervensi ke 24 (1 hari setelah intervensi ke 24). Penilaian ABI pretest dan postest dilakukan oleh seorang assessors atau evaluator yang tidak terlibat dalam pemberian intervensi pada penelitian ini. Asesor tidak mengetahui apakah responden tersebut masuk kedalam kelompok intervensi atau kelompok kontrol (blinded). Assessors tersebut sebelumnya sudah dilakukan pelatihan tentang cara pengukuran ABI dan uji persamaan persepsi dengan uji kappa (nilai uji kappa 0,874). Instrumen penelitian ini dibagai menjadi 3 yaitu kuesioner karakteristik responden, instrumen pengukuran gula darah sewaktu menggunakan glukotest (glukometer) yang sudah dilakukan kalibrasi, instrumen pengukuran ABI menggunakan Spignomanometer dan Doppler portable 8 MHz yang sudah dilakukan kalibrasi 
INA-PNPOLL5  Complete   Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries. 
Interventions: The participating subjects were given orally one film-coated caplet of test drug (febuxostat 80 mg film-coated caplet produced by PT Darya-Varia Laboratoria Tbk.) or one film-coated tablet of comparator drug (Feburic® 80 mg Film-Coated Tablet manufactured by Patheon France, S.A., France, imported by PT Meprofarm Pharmaceutical Industries, Indonesia) 
INA-ENHTMO9  Complete   BIOEQUIVALENCE STUDY OF FARSORBID® 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH CEDOCARD 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET MANUFACTURED BY PT DARYA-VARIA LABORATORIA TBK, UNDER LICENSE OF TAKEDA NETHERLAND B.V. 
Interventions: The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT Darya-Varia Laboratoria Tbk., under license of Takeda Netherland B.V., batch number LX1A057, manufacturing date on November 2021; expiration date on November 2024. The test drug was Farsorbid® 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Pratapa Nirmala, batch number FG 0801; manufacturing date on July 2021; expiration date on July 2023. subjects took 1 dose of ISDN products of either formulation (reference or test) as per randomization scheme in sitting position as scheduled. Subject took a glass of water (240 mL) 10-15 minutes before drug administration. After that subject was asked to put the tablet under the tongue and wait until the drug dissolved. 
INA-5S6XPK  Complete   Bioequivalence Study of Clonazepam 2 mg Tablets Manufactured by PT. Sunthi Sepuri in Comparison with Rivotril® 2 mg Tablets Manufactured by Roche Farma S.A., Spain 
Interventions: Subjects were given a single dose of 2 mg clonazepam tablet of either formulation (test or reference) with 240 mL of water 
INA-E3QOQ98  Complete   Bioequivalence Study of 500 mg Divalproex Sodium Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Depakote ER 500 mg Extended Release Tablets Manufactured by PT. Abbott Indonesia 
Interventions: Tablet batch number 25418XP manufacturing date 1 February 2021, expiration date 1 February 2023. The test drug was Divalproex Sodium Extended Release FC Tablets produced by PT. Novell Pharmaceutical Laboratoirs, batch number D21E06 manufacturing date June 2021 , expiration date May 2023. In the sampling day, each subject received a single-oral dose of 500 mg Divalproex Sodium, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose 
  Complete   NA 
Interventions: NA 
INA-3XEGQ4S  Complete   Bioequivalence Study of Gliclazide 60 mg Modified Release Tablets manufactured by PT Kimia Farma in comparison with Gliclazide 60 mg, Diamicron® Modified Release Tablets manufactured by Les Laboratories Servier – France, Registered by PT Darya Varia Laboratoria Tbk Bogor - Indonesia, Imported and Marketed by PT Servier Indonesia 
Interventions: Subjek diberikan 60 mg Gliclazide Modified Release Tablet yang diproduksi oleh PT Kimia Farma Tbk atau 60 mg Diamicron® Modified Release Tablet yang diproduksi oleh Les Laboratories Servier – France, yang diregistrasikan oleh PT Darya Varia Laboratoria Tbk Bogor – Indonesia, serta diimpor dan dipasarkan oleh PT Servier Indonesia Pfizer Healthcare Ireland dengan 240 mL air glukosa 20% setelah puasa 10 jam. Selanjutnya dilakukan periode washout 7 hari dan prosedur pemberian obat diulang untuk obat selanjutnya sesuai urutan yang telah ditentukan. 
INA-NN8ZFR4  Complete   BIOEQUIVALENCE STUDY OF LEVOFLOXACIN 500 MG FILM-COATED CAPLET (VOLOX® FILM COATED-CAPLET) PRODUCED BY PT INTERBAT IN COMPARISON WITH THE COMPARATOR DRUG (CRAVIT® 500 MG FILM-COATED TABLET) 
Interventions: The participating subjects were given orally one test drug (levofloxacin 500 mg film-coated caplet produced by PT Interbat) or one comparator drug (Cravit® 500 mg Film-Coated Tablet manufactured by PT Kalbe Farma Tbk., Indonesia, under license of Daiichi Sankyo Co., Ltd., Japan) after an overnight fast with 200 mL of water. 
INA-PYC9CAA  Complete   Bioequivalence Study of Glibenclamide 5 mg Caplet Produced by PT First Medipharma in Comparison with Daonil (5 mg Glibenclamide) Tablet Produced by PT Aventis Pharma, Jakarta - Indonesia 
Interventions: Test drug: Glibenclamide caplet 5 mg produced by PT First Medipharma - Indonesia. Reference drug: Daonil® (5 mg Glibenclamide) Tablet produced by PT Aventis Pharma - Indonesia. The subjects were asked to stay and fasted overnight (not less than 10 h) prior to the day of study. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA E092TGE  Complete   Bioequivalence Study of 160 mg Valsartan / 10 mg Amlodipine (Vamlopin ®) Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Exforge ®Film Coated Tablets (160 mg Valsartan / 10 mg Amlodipine) Manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novartis Indonesia 
Interventions: The reference drug was Exforge ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number BPV03; Manufacturing date March 2020; Expiry date February 2023; manufactured by Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland, Imported by PT. Novarrtis Indonesia. The test drug was Vamlopin ® film-coated tablets (160 mg Valsartan / 10 mg Amlodipine), Batch Number D20G01; Manufacturing date July 2020; Expired Date July 2022; produced by PT Novell Pharmaceutical Laboratories. Each subject received a single oral dose of one film-coated tablet of 160 mg Valsartan/10 mg Amlodipin, either as test or reference formulation were given with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose 
INA LTKMPXL  Complete   Bioequivalence study of Aspirin 100 mg, Aptor enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia in comparison with Aspirin 100 mg, Cardio Aspirin ® enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia 
Interventions: The References drug, Cardio Aspirin (Aspirin 100mg) enteric coated tablets manufactured by Bayer Pharma AG, Leverkusen - Germany for Bayer Consumer Care AG, Switzerland; imported by PT Bayer Indonesia; Batch Number BXJK5T1; Manufacturing Date on December 2020; Expired Date on December 2023. The Test Drug, Aptor (Aspirin 100mg) enteric coated tablet manufactured by PT Nicholas Laboratories Indonesia Batch Number 2C 100322, Manufacturing Date on March 2022; Expired Date on March 2024. In sampling day, subject took 1 dose of aspirin products of either formulation (Reference or Test) With 240 mL water according to randomization in each periods in sitting position. 
INA-MTZ4N9R  Complete   Bioequivalence Study of 50 mg/1000 mg Sitagliptin and Metformin Film-Coated Caplets Manufactured by PT. Lapi Laboratories in Comparison with 50 mg/1000 mg Janumet® Film-Coated Caplets Manufactured by Patheon Puerto Rico, Inc., Manati, Puerto Rico, USA. Released by Merck Sharp & Dohme BV, Haarlem Netherlands, registered by PT. Merck Sharp Dohme Pharma Tbk, Pasuruan - Indonesia 
Interventions: subjects were given a single dose of 1 caplet of either formulation (test or reference) with 240 ml of a 20% glucose solution in water. The caplet was swallowed whole without chewing or crushing. Subjects administered the drug products in sitting posture. Every 15 minutes subjects were administered of 60 mL of the glucose solution for up to 4 hours after dosing. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. 
INA-E092TGE  Complete   Bioequivalence Study of 2 mg Dienogest Tablets Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Visanne® Tablets Manufactured by Bayer Weimar GmbH und Co. KG, Germany Imported by PT. Bayer Indonesia 
Interventions: The reference drug was the market available Visanne® Tablet batch number WET75U manufacturing date February 2020, expiration date February 2023. The test drug was Dienogest 2 mg Tablet produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratoirs, batch number EEE316 manufacturing date June 2021 , expiration date June 2023. In the sampling day, each subject received a single-oral dose of 2 mg Dieogest, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose 
INA-6DH9H6R  Complete   Bioequivalence study of atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung in comparison with the comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one film-coated tablet of test drug (atorvastatin 20 mg film coated tablet produced by PT Otto Pharmaceutical Industries for PT Pertiwi Agung) or one film-coated tablet of comparator drug (Lipitor® 20 mg Film Coated Tablet manufactured by Pfizer Pharmaceuticals LLC Vega Baja Puerto Rico, USA; packed and released by Pfizer manufacturing Deutschland GmbH, Germany; imported by PT Pfizer Indonesia) 
INA-MEKSM9A  Complete   Bioequivalence study of moxifloxacin hydrochloride 400 mg film-coated caplet produced by PT Dexa Medica in comparison with the comparator drug (Avelox® 400 mg Film-Coated Tablet, manufactured by Bayer AG, Leverkusen, Germany, imported by PT Bayer Indonesia, Indonesia). 
Interventions: Test drug: Moxifloxacin hydrochloride 400 mg film-coated caplet produced by PT Dexa Medica. Reference drug: Avelox® 400 mg Film-Coated Tablet, manufactured by Bayer AG, Leverkusen, Germany, imported by PT Bayer Indonesia, Indonesia. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-98KBMQ4  Complete   Bioequivalence study of tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fed condition in healthy subjects 
Interventions: The participating subjects were given orally one film-coated tablet of test drug (tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film coated tablet produced by PT Kimia Farma Tbk.) or one tablet of comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. Subjects had to ingest this meal within 30 minutes or less. 
INA-15RFOKE  Complete   Bioequivalence study of 10/160 mg amlodipine/valsartan combination film-coated tablet produced by PT Dexa Medica in comparison with the comparator drug (Exforge® 10/160 mg Film-Coated Tablet, Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland imported by PT Novartis Indonesia) 
Interventions: Test drug: Valsartan/Amlodipine combination film-coated tablet 160/10 mg produced by PT Dexa Medica. Reference drug: Exforge® 10/160 mg Film-Coated Tablet, Novartis Farmaceutica SA, Spain for Novartis Pharma AG, Switzerland imported by PT Novartis Indonesia. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-M05FOH8  Initial   Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age 
Interventions: Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion will be given a booster dose of IndoVac vaccine. 
INA-F31CX8K  Complete   BIOEQUIVALENCE STUDY OF PREGABALIN 75 MG CAPSULES MANUFACTURED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH LYRICA® 75 MG CAPSULES MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, GERMANY, IMPORTED BY PT. PFIZER INDONESIA, JAKARTA 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subjek uji BE obat inovator dan obat uji dengan kandungan yang sama. Obat uji: Kapsul Pregabalin 75 mg produksi PT. Mahakam Beta Farma. Obat inovator: Kapsul Lyrica® produksi Pfizer Deutschland, Gmbh, Freiburg, Germany diimpor oleh PT. Pfizer Indonesia, Jakarta 
INA-YFRGA38  Complete   Bioequivalence study of Efavirenz 600 mg Film-Coated Tablet, Efanex manufactured by PT Amarox Pharma Global in comparison with Efavirenz 600 mg Tablet, Sustiva ® manufactured and distributed by Bristol-Myers Squibb Company Princeton, NJ 08543 USA 
Interventions: The reference drug was the market available Sustiva® (Efavirenz 600 mg) film coated tablet manufactured by Bristol-Myers Squibb Company Princeton, NJ 08543 USA; Batch number : ABQ5724A1; expired date : March 2023. The test drug was Efanex (Efavirenz 600 mg) film coated tablet manufactured by PT Amarox Pharma Global; Batch number : 08521F01G; manufacturing date : June 2021; expired date : May 2023. In sampling day subjects took one dose of Efavirenz products of either formulation (reference or test) after an overnight fast, as per randomization scheme with 250 mL of water in sitting position. The subjects blood samples will be taken at a certain times. 
INA-RGKH7Q4  Complete   Bioequivalence study of Ezetimibe 10 mg Tablet, Ezista manufactured by PT Amarox Pharma Global in comparison with Ezetimibe 10 mg Tablet, Ezetrol ® manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur 
Interventions: The reference drug was the market available Ezetrol® (ezetimibe 10 mg) tablet manufactured by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico; Packed by Schering – Plough Labo N.V., Belgium; Registered by PT Merck Sharp Dohme Pharma Tbk Pasuruan, Jawa Timur; Batch number : U019757; manufacturing date : March 2021; expired date : March 2023. The test drug was Ezista (ezetimibe 10 mg) tablet manufactured by PT Amarox Pharma Global; Batch number : 07521H02G; manufacturing date : August 2021; expired date : July 2023. In sampling day subjects took one dose of Ezetimibe products of either formulation (reference or test), as per randomization scheme with 250 mL of water in sitting position. 
INA-46CKYFL  Initial   Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Hepatitis B (Bio Farma) ® vaccine in Indonesian Population (Phase III) 
Interventions: Treatment Group: In-House Recombinant Hepatitis B Bio Farma Vaccine, three doses vaccine, intramuscular injection. Control Group: Recombinant Hepatitis B (Bio Farma) Vaccine, three doses vaccine, intramuscular injection. 
INA-LNARP0Q  Complete   Bioequivalence study of tenofovir disoproxil fumarate/ emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fasting condition in healthy subjects 
Interventions: The participating subjects were given orally one film-coated tablet of test drug (tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film coated tablet produced by PT Kimia Farma Tbk.) or one tablet of comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) after an overnight fast with 200 mL of water. 
INA-XMFSGW8  Complete   Bioequivalence Study of Nevirapine 200 mg Caplet Manufactured by PT. Kimia Farma Tbk in Comparison with Viramune® 200 mg Caplet Manufactured by Boehringer Ingelheim Ellas AE, Koropi, Greece for Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany 
Interventions: Subjects are given a single dose of 1 caplet of Nevirapine 200 mg of either formulation (test or reference) with 240 ml of water. 
INA-PY7N5MD  Recruit   Stop Transmisi Kusta PEP++ 
Interventions: Rejimen PEP++ berupa kombinasi obat rifampisin dan klaritromisin 
INA-TWWMH1T  Complete   Bioequivalence study of levodopa 100 mg and benserazide 25 mg dispersible tablet produced by PT Dexa Medica in comparison with the comparator drug (Madopar® 125 mg Dispersible Tablet, produced by Delpharm Milano S.r.l, Italy for F. Hoffmann-La Roche Ltd., Switzerland, imported by PT Boehringer Ingelheim Indonesia, distributed by PT Roche Indonesia). 
Interventions: Test drug : Levodopa 100 mg and Benserazide 25 mg Dispersible Tablet Produced by PT Dexa Medica. Reference drug: Madopar® 125 mg Dispersible Tablet, produced by Delpharm Milano S.r.l, Italy for F. Hoffmann-La Roche Ltd., Switzerland, imported by PT Boehringer Ingelheim Indonesia, distributed by PT Roche Indonesia. The subject's blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-3MOA7O8  Complete   BIOEQUIVALENCE STUDY OF ROSUVASTATIN 20 MG FILM-COATED TABLET PRODUCED BY PT MEPROFARM IN COMPARISON WITH THE COMPARATOR DRUG (CRESTOR® 20 MG FILM-COATED TABLET) 
Interventions: The participating subjects were given orally one film-coated tablet of the test drug (rosuvastatin 20 mg film-coated tablet produced by PT Meprofarm) or one filmcoated tablet of the comparator drug (Crestor® 20 mg Film-Coated Tablet manufactured by IPR Pharmaceuticals Inc., Puerto Rico for AstraZeneca UK Limited, United Kingdom, imported by PT AstraZeneca Indonesia, Indonesia) after an overnight fast with 200 mL of water. 
INA-AOW6BG7  Complete   BIOEQUIVALENCE STUDY OF ETORICOXIB 120 MG (ECOROXIB® 120) FILM-COATED TABLET MANUFACTURED BY PT DIPA PHARMALAB INTERSAINS IN COMPARISON WITH THE COMPARATOR DRUG (ARCOXIA™ 120 MG FILM-COATED TABLET) 
Interventions: The participating subjects were given orally one test drug (Ecoroxib® 120 mg film-coated tablet manufactured by PT Dipa Pharmalab Intersains) or one comparator drug (Arcoxia™ 120 mg Film-Coated Tablet) after an overnight fast with 200 mL of water. 
INA-D683KD6  Complete   Bioequivalence Study of Bisoprolol Fumarate 10 mg (Concaprol® 10) Film-Coated Tablets Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with Concor® 10 mg Film-Coated Tablets Manufactured by PT. Merck Indonesia Tbk, Jakarta Under License From Merck KGaA, Germany 
Interventions: Subjects were given a single dose of 10 mg Bisoprolol of test drug or of reference drug with 240 mL of water 
INA-0B7K35C  Complete   Bioequivalence Study of 100 mg Kaltrofen Enteric Coated Tablet Manufactured by PT. Kalbe Farma Tbk in Comparison with 100 mg Ketoprofen Enteric Coated Tablet Manufactured by PT. Novell Pharmaceutical Laboratories, Bogor. 
Interventions: subjects were given a single dose of 100 mg Ketoprofen of test drug or of reference drug with 240 mL of water. 
INA-BC2YXAW  Complete   Bioequivalence Study of 150 mg Fluconazole Capsules Manufactured by PT. Kalbe Farma Tbk in Comparison with 150 mg Diflucan® Capsules Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, under the authority of Pfizer Inc., New York, N.Y., USA. 
Interventions: Subjects were given a single dose of 150 mg fluconazole of either formulation (test or reference) with 240 mL of water 
INA-P33PZRL  Complete   Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsules Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Losec 20 mg Capsules Marketed by AstraZeneca Limited, New Zealand. 
Interventions: The reference drug was Losec® 20 mg capsules marketed by AstraZeneca Limited, New Zealand and the test drug was Omeprazole 20 mg delayed release capsules produced by PT Etercon Pharma for PT Novell Pharmaceutical Laboratories. On the sampling day, each subject received a single oral dose of 20 mg Omeprazole, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. 
INA-OR87W37  Complete   Bioequivalence Study of 75 mg Oseltamivir Capsule Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Tamiflu® 75 mg Capsule Manufactured by Cenexi SAS, France, For F. Hoffmann-La Roche Ltd., Switzerland, Importad by PT. Boehringer Ingelheim Indonesia. 
Interventions: The reference drug was the market available Tamiflu® 75 mg Capsule batch number F0259B01; manufacturing date October 2019; expiration date October 2023. The test drug was Oseltamivir® 75 mg Capsule produced by PT Novell Pharmaceutical Laboratories, batch number D21D30 manufacturing date May 2021; expiration date May 2023. In the sampling day, each subject received a single oral dose of 75 mg Oseltamivir, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. 
INA-G3OW540  Complete   Dose-finding Study for AdmirSC-2f Vaccine 
Interventions: Intervention Name: Biological Product: AdmirSC-2f Intervention Description: Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months. Dose level of study intervention divided into: - Low Dose: 50 mcg of antigen with 250 mcg of Al(OH)3 - Median Dose: 100 mcg of antigen with 250 mcg of Al(OH)3 - High Dose: 100 mcg antien with 500 mcf of Al(OH)3 - Control (Placebo): 250 mcg of Al(OH)3 
INA-NQQB4Z0  Complete   Bioequivalence Study of Pantoprazole 40 mg Enteric Coated Tablets Manufactured by PT Kimia Farma in Comparison with Pantoprazole 40 mg, Pantozol® Gastro Resistant Tablets Manufactured by Takeda GmbH – Germany, Registered by PT Takeda – Indonesia. 
Interventions: An Open label, randomized, three-periods, three treatments, three way partial replicate in fasting condition. 
INA-PQSXYHX  Complete   Bioequivalence Study of 100 mg Sitagliptin Phosphate Film-Coated Tablet Manufactured by PT. Kimia Farma (Persero) Tbk. in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia 
Interventions: Randomized, single blind, two-period, two-treatment, two-sequence, single dose, two-way crossover study dengan periode washout period 1 minggu dalam kondisi puasa. Pemberian Obat Subyek diinstruksikan untuk berpuasa semalaman (8 jam) sebelum pemberian obat hingga 4 jam setelah pemberian obat. Subyek diberikan dosis tunggal 1 Tablet Sitagliptin Phosphate 100 mg baik obat uji maupun obat komparator dengan 240 ml air dalam posisi duduk. Tablet harus ditelan utuh tanpa dipecah maupun dikunyah. Subyek diminta untuk tetap berada dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian obat. 
INA-OL37WNF  Complete   ioequivalence Study of 80 mg Gliclazide Tablet Manufactured by PT. Kimia Farma Tbk in Comparison with 80 mg Diamicron ® Tablet Manufactured by PT. Darya-Varia Laboratoria Tbk, Indonesia under license of Les Laboratories Servier, France. 
Interventions: Randomized, single blind, two-period, two-treatment, two-sequence, single dose, two-way crossover study dengan periode washout period 1 minggu dalam kondisi puasa. Pemberian Obat Subyek diinstruksikan untuk berpuasa semalaman (8 jam) sebelum pemberian obat hingga 4 jam setelah pemberian obat. Subyek diberikan dosis tunggal 1 Tablet Gliclazide 80 mg baik obat uji maupun obat komparator dengan 240 ml air dalam posisi duduk. Tablet harus ditelan utuh tanpa dipecah maupun dikunyah. Subyek diminta untuk tetap berada dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian obat. Subjek diberikan 100 ml larutan glukosa 100 ml pada jam ke-1, 2, san 3 setelah pemberian obat. 
INA-FQ206  Complete   BIOEQUIVALENCE STUDY OF GLIBENCLAMIDE 5 MG TABLET (LATIBET® 5 TABLET) PRODUCED BY PT IFARS PHARMACEUTICAL LABORATORIES WITH THE COMPARATOR DRUG (DAONIL® 5 MG TABLET, PT AVENTIS PHARMA, INDONESIA) 
Interventions: The participating subjects were given orally one film-coated tablet of the test drug (glibenclamide 5 mg tablet (Latibet® 5 Tablet) produced by PT IFARS Pharmaceutical Laboratories) and one film coated tablet of the comparator drug (Daonil® 5 mg Tablet, PT Aventis Pharma, Indonesia) after an overnight fast with 240 mL of 20% glucose solution in water according to the predetermined sequence. 
INA-NYND6LT  Complete   Bioequivalence study of diclofenac sodium 50 mg enteric coated tablets produced by PT Pabrik Pharmasi Zenith in comparison with the comparator drug (Voltaren® 50 mg Enteric Coated Tablet, PT Novartis Indonesia, Indonesia) 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat pembanding dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Tablet salut enterik diclofenac sodium 50 mg produksi PT Pabrik Pharmasi Zenith. Obat pembanding: Tablet Salut Enterik Voltaren® 50 mg. Obat-obat tersebut diminum dengan 200 mL air. 
INA-P1HLHA  Complete   Bioequivalence study of fenofibrate 160 mg film-coated caplet produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl Supra 160 mg Film-Coated Tablet manufactured by Recipharm Fontaine, France imported by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Kaplet salut selaput Fenofibrate 160 mg produksi PT Guardian Pharmatama. Obat inovator: Tablet Salut Selaput Lipanthyl Supra 160 mg. Obat-obat tersebut diminum dengan 200 mL air. 
INA-KADGW39  Complete   Bioequivalence Study of Ciprofloxacin 500 mg Caplets Manufactured by PT. Trifa Raya Laboratories in Comparison with Ciproxin® 500 mg Film-Coated Tablets Manufactured by Bayer Pharma AG, Leverkusen, Germany, Imported and Packed by PT. Bayer Indonesia. 
Interventions: Subjects were given a single dose of 500 mg Ciprofloxacin of test drug or of reference drug with 240 mL of water. 
INA-H300DEF  Complete   BIOEQUIVALENCE STUDY OF CLOPIDOGREL 75 MG FILM-COATED TABLET PRODUCED BY PT NOVELL PHARMACEUTICAL LABORATORIES IN COMPARISON WITH THE COMPARATOR DRUG (PLAVIX® 75 MG FILM-COATED TABLET MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA) 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Tablet salut selaput clopidogrel 75 mg produksi PT Novell Pharmaceutical Laboratories. Obat inovator: Tablet salut selaput Plavix® 75 mg). Obat-obat tersebut diminum dengan 250 mL air. 
INA-TPD1E  Complete   BIOEQUIVALENCE STUDY OF DOXYCYCLINE 100 MG CAPSULE PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (VIBRAMYCIN® 100 MG CAPSULE, PRODUCED BY FARMASIERRA MANUFACTURING SL., SPAIN, REGISTERED BY PFIZER HEALTHCARE IRELAND) 
Interventions: Subjek diberikan 100 mg doxycycline kapsul yang diproduksi oleh PT Kimia Farma Tbk atau 100 mg Vibramycin yang diproduksi oleh Farmasierra Manufacturing S.L., Spain, yang diregistrasikan oleh Pfizer Healthcare Ireland dengan air minum 200 mL setelah puasa 8 jam. Selanjutnya dilakukan periode washout 9 hari dan prosedur pemberian obat diulang untuk obat selanjutnya sesuai urutan yang telah ditentukan. 
INA-XFQ6052  Complete   Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT. Bernofarm in Comparison with 200 mg Lipanthyl® 200 M Capsules Manufactured by Recipharm Fontaine, France, imported and repacked by PT. Combiphar, Bandung, Indonesia. 
Interventions: Subjects were given a single dose of fenofibrate 200 mg of either formulation (test or reference) with 240 ml of water. 
INA-MS12MM9  Complete   Bioequivalence Study of 40 mg Olmesartan Medoxomil (Olmevel) Film Coated Tablets Produced by Pt. Novell Pharmaceutical Laboratories in Comparison with Olmetec 40 mg Film Coated Tablets Manufactured by Daiichi Sankyo Europe GmbH, Germany, packed and Released by Pfizer Manufacturing Deutschland GmbH, Germany, Imported by PT. Pfizer Indonesia 
Interventions: The reference drug was the market available Olmetec® 40 mg Film Coated Tablets batch number DY4208; manufacturing date March 2020; expiration date February 2022. The test drug was Olmevel® 40 mg film coated caplet produced by PT Novell Pharmaceutical Laboratories, batch number D20H03 manufacturing date August 2020; expiration date August 2022. In the sampling day, each subject received a single oral dose of 40 mg olmesartan medoxomil, either as test or reference formulation administered along with 220 mL of water. The dose was taken 1t 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. 
INA-OBD04O  Complete   Uji Bioekivalensi Kapsul Aldisa® SR (Loratadin 5 mg dan Pseudoefedrin Sulfat 120 mg) Produksi PT Sanbe Farma Dibandingkan terhadap Clarityn-D® Repetabs (Loratadin 5 mg dan Pseudoefedrin Sulfat 120 mg) Produksi Schering-Plough Labo N.V. Belgia Diimpor oleh Bayer (South East Asia) PTE LTD, Singapura pada Subjek Sehat 
Interventions: Pengujian ketersediaan hayati loratadin dan pseudoefedrin dari Aldisa® SR yang diproduksi PT. Sanbe Farma dilakukan secara komparatif pada subjek sehat dengan desain penelitian silang lengkap menggunakan Clarityn-D® Repetabs sebagai obat komparator dan sampel plasma untuk pengujian. Obat diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00-07.00 WIB dengan 220 mL air pada suhu ruang 
INA-T79N  Complete   Bioequivalence study of Sharox 500 (500 mg Cefuroxime) film coated caplet produced by PT. Pratapa Nirmala in comparison with Zinnat (500 mg Cefuroxime) film coated tablet produced by Glaxo Wellcome Operations, Barnard Castle, UK, imported by PT. Glaxo Wellcome Indonesia 
Interventions: The reference drug was the market available Zinnat® 500 mg film coated tablet batch number 747E; manufacturing date June 2019; expiration date June 2022. The test drug was Sharox® 500 mg film coated caplet produced by PT Pratapa Nirmala, batch number FC 0038 manufacturing date March 2021; expiration date March 2023. In the sampling day, subjects were took 1 Cefuroxime 500 mg products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during the period of 1 hour before dosing until 2 hours after dosing. 
INA-WQ16ZYB  Complete   Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Bernofarm in Comparison with Exjade® 500 mg Dispersible Tablets Manufactured by Novartis Pharma Stein AG for Novartis Pharma AG, Basel, Switzerland, Imported by PT. Novartis Indonesia, Jakarta, Indonesia 
Interventions: subjects were given a single dose of 500 mg deferasirox of either formulation (test or reference) with 240 ml of water. Tablets should not be chewed or swallowed whole. The drug was completely dispersed by stirring in a glass of water (100 to 200 ml) until a fine suspension was obtained. Subjects administered the suspension in sitting posture. After swallowing the suspension, any residue were re-suspended in the remaining water, and swallowed all. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing. 
INA-TK3MF5E  Complete   Bioequivalence study of Etoricoxib 120 mg Film Coated Tablet, Scancox manufactured by PT Tempo Scan Pacific Tbk in comparison with Etoricoxib 120 mg Film Coated Tablet, ArcoxiaTM manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java 
Interventions: Subject was given a single dose of Test product, Scancox (Etoricoxib) 120 mg Film Coated Tablet manufactured by PT. Tempo Scan Pacific, or Reference product, ArcoxiaTM (Etoricoxib) 120 mg Film Coated Tablet manufactured by Rovi Pharma Industrial Services S.A., registered and packed by PT Merck Sharp Dohme Pharma Tbk Pasuruan, East Java. Study drug administration was conducted after at least 10 hours overnight fast. Blood sample collection for each period was taken from each subject at certain time intervals post dosing. Study drug administration and blood sample collection were conducted in 2 (two) periods with wash out period of at least seven (7) days. 
INA-NCZR265  Complete   Bioequivalence Study of 400 mg Moxifloxacin (Moximox) Film Coated Caplets Produced by PT. Imedco Djaja in Comparison with Avelox 400 mg Film Coated Tablets Produced by Bayer AG, Germany, imported by PT. Bayer Indonesia 
Interventions:
INA-W5R2TS5  Complete   Bioequivalence Study of 500 mg Capecitabine Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 500 mg Xeloda® Film-Coated Tablets Manufactured by Excella GmbH & Co KG, Feucht, Germany for F. Hoffmann-La Roche Ltd, Basel, Switzerland, Imported by PT. Boehringer Ingelheim Indonesia, Bogor, Indonesia. 
Interventions: Subjects were given a single dose of 500 mg Capecitabine of test drug or of reference drug with 240 mL of water. 
INA-TW4CQQL  Complete   Bioequivalence study of Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex in comparison with Cedocard 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland 
Interventions: The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland, batch number DX1A037, expiration date on April 2024. The test drug was Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex, batch number 22A (SEP21A01); manufacturing date on September 2021; expiration date on September 2023. In the morning of the sampling as scheduled, subjects took one dose of ISDN products of either formulation (reference or test), as per randomization scheme in sitting position. Subjects drank a glass of water (240 mL) 10-15 minutes before placing a sublingual tablet. Subjects put drug sublingually (under tongue) until the drug dissolved. Water intake is permitted anytime except during the period of 1 hour before dosing until 2 hours after dosing. 
INA-D02FAHP  Recruit   An innovative α‐calcium sulfate hemihydrate bioceramic as a potential bone graft substitute 
Interventions: Persiapan Preoperatif - Pemeriksaan rutin pra-bedah minor. - Foto. - Pembersihan gigi (scalling). - CT-scan pra-bedah (CBCT). - Tanda tangan informed consent. - Diskusikan rencana bedah minor dengan pasien atau orang tua pasien. - Pemberian antibiotik profilaksis Prosedur pembedahan: Sebuah x-ray periapikal pra operasi akan diambil untuk menilai posisi gigi dan struktur tulang di sekitarnya. Sebelum dilakukan pencabutan gigi pada kelompok control dan eksperimen, Prosedur pencabutan gigi atraumatik harus dilakukan dengan anestesi lokal dan steril dengan kerusakan minimal pada jaringan lunak (gingiva) dan jaringan keras hingga puncak tulang. Menghindari kerusakan tepi tulang alveolar marginal biasanya dilakukan dengan menggunakan elevator. Setelah luksasi, pencabutan gigi akan dilakukan dengan menggunakan forsep. Setelah pencabutan gigi, kuretase tajam harus dilakukan untuk menghilangkan sisa-sisa ligamen periodontal serta jaringan lunak lainnya. Semua ekstraksi akan dilakukan dengan hati-hati untuk mencegah kerusakan pada dinding soket dan papila interproksimal. Soket segar dapat α-CSH (kelompok eksperimen) atau dibiarkan tanpa diberikan biomaterial pengganti tulang (kelompok control). Jumlah α-CSH yang akan diterapkan secara alami akan tergantung pada ukuran soket yang perlu diisi; Menggunakan elevator periosteal atau teknik jarum suntik, bahan dikirim ke lokasi ekstraksi dan dikemas dengan lembut ke puncak situs. Bahan akan dicangkokkan ke dalam soket hingga 2 mm apikal ke tepi jaringan lunak; kami mengharapkan 3 gram sebagai dosis total maksimum per pasien. Penutupan luka primer akan dicapai dengan jahitan resorbable. Pasien akan diberikan antibiotik dan penghilang rasa sakit yang sesuai selama 7 hari pasca operasi. Instruksi Post-operatif: • Makanan lunak • Berkumur setelah makan • Membatasi aktivitas untuk tiga hari pertama setelah bedah Follow-up CT-scan atau CBCT: 6 bulan setelah bedah 
INA-RLEE403  Complete   BIOEQUIVALENCE STUDY OF COLCHICINE 0,5 MG TABLET PRODUCED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH THE COMPARATOR PRODUCT COLCHICINE SANDOZ® (0,5 MG COLCHICINE) TABLET PRODUCED BY TIOFARMA B.V. 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama. Obat uji: Tablet Colchicine 0,5 mg produksi PT. Mahakam Beta Farma. Obat inovator: Tablet Colchicine Sandoz® produksi TIOFARMA B.V., didaftarkan oleh SANDOZ B.V. 
INA-DBQYT59  Complete   BIOEQUIVALENCE STUDY OF ATORVASTATIN 20 MG FILM COATED TABLET PRODUCED BY PT HEXPHARM JAYA LABORATORIES IN COMPARISON WITH THE COMPARATOR DRUG LIPITOR® 20 MG FILM COATED TABLET MANUFACTURED BY PFIZER PHARMACEUTICALS LLC VEGA BAJA PUERTO RICO, USA 
Interventions: Penelitian ini dilakukan dengan memberikan kepada masing-masing subyek uji BE obat inovator dan obat uji dengan kandungan sama pada urutan yang telah ditentukan. Obat uji: Tablet salut selaput atorvastatin 20 mg produksi PT Hexpharm Jaya Laboratories. Obat inovator: Tablet Salut Selaput Lipitor® 20 mg). Obat-obat tersebut diminum dengan 250 mL air. 
INA-XA2GFG  Complete   BIOEQUIVALENCE STUDY OF PIOGLITAZONE 30 MG TABLET PRODUCED BY PT ACTAVIS INDONESIA IN COMPARISON WITH THE COMPARATOR PRODUCT ACTOS® 30 MG TABLET, PT TAKEDA INDONESIA 
Interventions: subyek penelitian diberikan obat inovator dan obat uji dengan kandungan yang sama. Obat Uji : Pioglitazone 30 mg tablet, manufactured by PT Actavis Indonesia. Innovator : Actos® 30 mg Tablet, contains 30 mg of pioglitazone manufactured by PT Takeda Indonesia, 
INA-FFO44FZ  Initial   A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia 
Interventions: Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection; Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection 
INA-KPO7OD6  Complete   Bioequivalence study of atorvastatin 20 mg film-coated tablet produced by PT Dexa Medica for PT Beta Pharmacon in comparison with the comparator drug (Lipitor® 20 mg Film-Coated Tablet manufactured by Pfizer Manufacturing Deutschland GmbH, Germany, registered by PT Pfizer Indonesia, Indonesia) 
Interventions: Test drug : Atorvastatin Film-Coated Tablet 20 mg produced by PT Dexa Medica for PT Beta Pharmacon. Reference drug Lipitor® 20 mg Film-Coated Tablet manufactured by Pfizer Manufacturing Deutschland GmbH, Germany, registered by PT Pfizer Indonesia, Indonesia The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-W6F  Complete   Bioequivalence study of Gabapentin 300 mg capsule manufactured by PT. Ifars Pharmaceutical Laboratories (Galtenix 300 mg) in comparison with Neurontin® 300 mg capsule manufactured by Pfizer Pharmaceutical LLC, Vega Baja, Puerto Rico, packaged by Pfizer Manufacturing Deutschland GmbH Bettriebsstatte Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta, Indonesia. 
Interventions: Subjects were given a single dose of 300 mg gabapentin of either formulation (test or reference) with 240 ml of water 
INA-Q3MRSSX  Recruit   Medwell Study 
Interventions: Treatment group: Subject receiving regular diabetes treatment with additional Medwell digital application. Control group: Subjects receiving regular diabetes treatment without additional Medwell digital application. 
INA-NZ1GBF8  Complete   Bioequivalence study of clopidogrel 75 mg film-coated tablet produced by PT Dexa Medica for PT Beta Pharmacon in comparison with the comparator drug (Plavix® 75 mg Film Coated Tablet manufactured by PT Aventis Pharma, Indonesia, under license by Sanofi Clir SNC, France) when administered under fasting condition in healthy subjects 
Interventions: Test drug: Clopidogrel Film-Coated Tablet 75 mg produced by PT Dexa Medica for PT Beta Pharmacon. Reference drug: Plavix® 75 mg Film-Coated Tablet, Manufactured by PT Aventis Pharma, Jakarta – Indonesia, Under license by Sanofi Clir SNC, Paris – France. The subject's blood samples will be taken at a certain time. Drug administration, drink and meals for subjects, and subject activities will be standardized during the study period. 
INA-ABBA4Y  Complete   Bioequivalence Study of 100 mg Sitagliptin Film-Coated Tablet Manufactured by PT. Hexpharm Jaya in Comparison with 100 mg Januvia® Film-Coated Tablet Manufactured by Merck Sharp & Dohme Ltd., Cramlington, England, Registered and Packed by PT. Merck Sharp Dohme Pharma Tbk, Pandaan, Indonesia 
Interventions: Subjects were given a single dose of 100 mg sitagliptin film-coated tablet (either test or reference according to randomization code) with 240 mL water. 
INA-B4C8H82  Recruit   Observer-Blind, Randomized, Controlled Study of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older 
Interventions: Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 1 booster dose vaccine intramuscular injection; Control group: SARS-CoV-2 mRNA Pfizer Vaccine, 1 booster dose vaccine intramuscular injection 
INA-HF77OE  Complete   Bioequivalence Study of Diclofenac sodium 50 mg enteric-coated tablet, Nadifen 50 manufactured by PT Global Multi Pharmalab in comparison with Diclofenac sodium 50 mg enteric-coated tablet, Voltaren ® manufactured by PT Novartis Indonesia. 
Interventions: The reference drug was the market available Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Novartis Indonesia, batch number ID 5893; manufacturing date on April 2021; expired date on March 2024. The test drug was Nadifen (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Global Multi Pharmalab, batch number RF 08105; manufacturing date on August 2021; expired date on August 2024. In sampling day, subjects took one dose of Diclofenac Sodium products of either formulation (reference or test) with 250 mL of water according to randomization in each period in sitting position. 
INA-CHKPBQ  Complete   BIOEQUIVALENCE STUDY OF DIUTENSI TABLET (40 MG FUROSEMIDE) PRODUCED BY PT. KONIMEX IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET MANUFACTURED BY PT. SANOFI AVENTIS INDONESIA 
Interventions: The reference drug was the market available lasix® (40 mg Furosemide) tablet produced by PT Sanofi Aventis Pharma, Jakarta-Indonesia, batch number 1DN016; manufacturing date on May 2021; expiration date on April 2022. The test drug was Diutensi (Furosemide) tablet produced by PT. Konimex, batch number 1P4L9(SEP21A02); manufacturing date on 02 September 2021; expiration date on 02 September 2023. In sampling day, subjects took one dose of Furosemide products of either formulation (reference or test), as per randomization scheme with 240 ml of water in sitting position. 
INA-S857CAF  Complete   Bioequivalence Study of Glibenclamide 5 mg caplet produced by PT First Medipharma in comparison with Daonil (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia 
Interventions: The reference drug was the market available Daonil® (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia, batch number ODN008A; manufacturing date on May 2020; expiration date on April 2023. The test drug was Glibenclamide 5 mg caplet produced by PT. First Medipharma, batch number P003214; manufacturing date on 22 November 2021; expiration date on 22 November 2023. In sampling day, subjects took one dose of Glibenclamide products of either formulation (reference or test), as per randomization scheme with 240 ml of a 10% glucose solution in sitting position. 
INA-YGL0K5S  Complete   Bioequivalence study of Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala in comparison with Cefspan (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc. 
Interventions: The reference drug was the market available Cefspan® (100 mg/5 mL Cefixime) dry syrup produced by PT Dankos Farma for PT Kalbe Farma Tbk., under license of Astellas Pharma Inc, batch number DCEFA00192; manufacturing date on July 2020; expiration date on July 2022. The test drug was Fixacep (100 mg/5 mL Cefixime) dry syrup produced by PT Pratapa Nirmala, batch number 8AB005; manufacturing date on February 2022; expiration date on February 2024. Subjects took one dose of Cefixime products of either formulation (reference or test), as per randomization scheme with 240 ml of water in sitting position. 
INA-G7MDHB7  Complete   Bioequivalence study of Renabetic (5 mg Glibenclamide) tablet produced by PT Pratapa Nirmala in comparison with Daonil (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia 
Interventions: The reference drug was the market available Daonil® (5 mg Glibenclamide) tablet produced by PT Aventis Pharma, Jakarta-Indonesia, batch number 0DN008A; manufacturing date on May 2020; expiration date on April 2023. The test drug was Renabetic (5 mg Glibenclamide) tablet produced by PT. Pratapa Nirmala, batch number FG 1561; manufacturing date on July 2021; expiration date on July 2023. Subjects took one dose of Glibenclamide products of either formulation (reference or test), as per randomization scheme with 240 ml of a 10% glucose solution in sitting position. 
INA-ZG4DL9D  Recruit   Vaksin Merah Putih 
Interventions: UNAIR Inactivated COVID-19 Vaccine (Study Product) dan Sinovac – BioFarma COVID 19 vaccine (Control) 2 dosis secara intramuscular selang 28 hari 
INA-YYAG360  Complete   Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan. 
Interventions: Subjects were given a single dose of 30 mg lansoprazole of either formulation (test or reference) with 240 ml of water 
INA-RYRAQTO  Complete   Bioequivalence Study of 20 mg Omeprazole (Lokev®) Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Soedertalie, Sweden, Imported by PT. AstraZeneca Indonesia. 
Interventions: subjects were given a single dose of 20 mg omeprazole of either formulation (20 mg Lokev® Delayed-Release capsule or 20 mg Losec® capsule) with 240 mL of water 
INA-D4HEQMP  Complete   Bioequivalence study of Zibramax (500 mg Azithromycin) film coated caplet produced by PT Guardian Pharmatama in comparison with Zithromax (500 mg Azithromycin) film coated tablet manufactured by PT Pfizer Indonesia 
Interventions: The reference drug was the market available Zithromax® (500 mg Azithromycin) film coated tablet manufactured by PT. Pfizer Indonesia, batch number A210081; manufacturing date on April 2021; expiration date on March 2025. The test drug was Zibramax (500 mg Azithromycin) film coated caplet produced by PT. Guardian Pharmatama, batch number T210717; manufacturing date on 21st July 2021; expiration date on July 2023. In the sampling day, subjects took 1 dose of Azithromycin products of either formulation (reference or test) with 240 mL of water in sitting position as scheduled. Water intake was permitted except during 1 hour before dosing until 2 hours after dosing. 
INA-F0M6LGX  Complete   Bioequivalence study of Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex in comparison with Cedocard 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland 
Interventions: The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT. Darya-Varia Laboratoria Tbk. under license by Takeda Netherland, batch number DX1A037, expiration date on April 2024. The test drug was Sorbicard (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Konimex, batch number 22A (SEP21A01); manufacturing date on September 2021; expiration date on September 2023. In the morning of the sampling as scheduled, subjects took one dose of ISDN products of either formulation (reference or test), as per randomization scheme in sitting position. Subjects drank a glass of water (240 mL) 10-15 minutes before placing a sublingual tablet. Subjects put drug sublingually (under tongue) until the drug dissolved. Water intake is permitted anytime except during the period of 1 hour before dosing until 2 hours after dosing. 
INA-W5ML2T2  Initial   Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19 (NOVATION-1) 
Interventions: The selected dose regimen is 20 μg aerosolized Novaferon or placebo, administered using a vibrating mesh nebulizer, twice per day with an interval between doses of at least 4 hours, for 10 days, or until discharged, if discharge occurs within 10 days. Each 20 μg dose of Novaferon (2 x 1 mL vials) or placebo will be administered to patients by nebulizer for approximately 10 minutes. The supplied matching placebo formulation is identical in physical appearance to the active formulation and contains the same inactive ingredients. The study treatment/placebo will be given in conjunction with SOC treatment(s) 
INA-R5752S9  Recruit   Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax – Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III) 
Interventions: Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection 
INA-P7NSA4P  Recruit   A Phase 2, Observer-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia 
Interventions: Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine with 28 days interval, intramuscular injection Control group: Placebo, 2 doses of placebo with 28 days interval, intramuscular injection 
INA-H0MOBSZ  Complete   : Bioequivalence study of 100 mg sitagliptin film-coated tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in comparison with the comparator drug (Januvia® 100 mg Film-Coated Tablet manufactured by Merck Sharp & Dohme Ltd., England, registered and packaged by PT Merck Sharp Dohme Pharma Tbk., Indonesia. 
Interventions: Test drug : Sitagliptin film coated tablet 100 mg produced by PT Dexa Medica. Reference drug : Januvia® 100 mg Film-Coated Tablet, Manufactured by Merck harp & Dohme Ltd., England, Registered and Packaged by PT Merck Sharp Dohme Pharma TBK., Indonesia. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-ZBMDZ7C  Initial   Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy (MetLep Trial) 
Interventions: Uji klinik fase 2, acak (1:1), double-blind, terkontrol. Metformin sebagai obat uji dibandingkan dengan plasebo. Subyek menerima pengobatan standar selama 48 minggu, yaitu dengan multidrug therapy (MDT yang terdiri atas dapson, klofazimin, dan rifampisin). Metformin/plasebo dikombinasikan dengan MDT selama 24 minggu pertama. Follow-up dilakukan setelah selesai intervensi metformin/plasebo selama 24 minggu. 
INA-ZN6M5MG  Recruit   Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria 
Interventions: Sanaria® PfSPZ Vaccine: Radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) administered by direct venous inoculation (DVI). Normal Saline (0.9% NaCl): The placebo control administered by DVI. Sanaria® PfSPZ-CVac: Infectious, aseptic, purified, cryopreserved PfSPZ (Sanaria® PfSPZ Challenge) administered by DVI to individuals taking chloroquine (CQ) chemoprophylaxis. Normal Saline (0.9% NaCl): The placebo control administered by DVI to individuals taking CQ chemoprophylaxis. Diluent. The diluent for PfSPZ Vaccine and PfSPZ Challenge will be phosphate buffered saline (PBS) with 1% human serum albumin. 
INA-EPQFKH4  Complete   Bioequivalence study of Diutensi tablet (40 mg Furosemide) produced by PT. Konimex in comparison with Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia 
Interventions: The reference drug was the market available Lasix® (40 mg Furosemide) tablet manufactured by PT. Sanofi Aventis Indonesia, batch number 1DN016, expiration date on April 2024. The test drug was Diutensi tablet (40 mg Furosemide) produced by PT. Konimex, batch number F1P4L9(SEP21A02); manufacturing date on September 2021; expiration date on September 2023. 
INA-ME8QS7  Complete   Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia. 
Interventions: Subjects were given a single dose of Ticagrelor 90 mg Film-Coated Tablets or Brilinta® 90 mg Film-Coated Tablets under fasted condition. The drug was administered with 240 mL water. 
INA-LPAEZM  Complete   Bioequivalence study of 1000 mg Metformin HCl extended release caplet manufactured by PT. Hexpharm Jaya (Nevox XR 1000 mg Caplet) for Formula A and Formula B in comparison with 1000 mg Glucophage® XR extended release tablet manufactured by Merck Sante SAS, France, imported by PT. Merck Indonesia Tbk., Jakarta 
Interventions: Subjects were given a single dose of 1 extended release caplet of the test drug (Nevox XR 1000 mg Caplet formula A or formula B) or 1 extended release tablet of the reference drug (Glucophage® XR extended release 1000 mg Tablet) under fasted condition. The drug was administered with 240 ml of 20% glucose solution in water. 
INA-XLLSX2Z  Complete   Bioequivalence study of Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma in comparison with Madopar® 125 mg T tablet (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen 
Interventions: The reference drug was the market available Madopar® 125 mg T tabletten (100 mg Levodopa and 25 mg Benserazide HCL) manufactured by Roche Pharma AG, 79630 Grenzach-Whylen, batch number M3211M1, expiration date on December 2024. The test drug was Levazide® tablet (100 mg Levodopa and 25 mg Benserazide HCL) produced by PT Pyridam Farma, batch number PELEV001.02-05; manufacturing date on October 2021; expiration date on October 2023 
  Initial   NA 
Interventions: Pemberian obat uji dilakukan setelah puasa minimal 10 jam semalam. 
INA-HAWRFA8  Recruit   BDB-001 
Interventions: a. Treatment group: conventional treatment + BDB-001 Injection b. Control group: conventional treatment 
INA-N2ZX642  Initial  
Interventions: Treatment Arm 1 Bevagen/Bevacizumab(Once each cycle for 6 cycles)+ Oxaliplatin (Once each cycle for 6 cycles) + Capecitabine (q.d. 14 days each cycle for 6 cycles) Treatment Arm 2 Avastin (Once each cycle for 6 cycles) + Oxaliplatin(Once each cycle for 6 cycles) + Capecitabine (q.d. 14 days each cycle for 6 cycles) 
INA-OYBE2M0  Initial   Proxalutamide 
Interventions: Treatment Arm 1 : Proxalutamide 300 mg (q.d 14 days) + SoC selama 14 hari Treatment Arm 2 : Placebo (q.d 14 days)+ SoC for 14 days selama 14 hari 
INA-MNL47N9  Recruit   ARCoV-005 
Interventions: Vaksin Aktif ARCoV : Placebo/ Normal Saline dengan perbandingan 1:1 
INA-WCMM  Complete   Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients. 
Interventions: Arm 1 = Niclosamide 432mg (i.m.) + Remdesivir Arm 2 = Niclosamide 960mg (i.m.) + Remdesivir Arm 3 = Placebo (i.m.) + Remdesivir 
INA-EF623  Recruit   Dose-finding Study for AdmirSC-2f Vaccine 
Interventions: Intervention Name: AdmirSC-2f (Biological) Intervention Description: Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. Dose level of study intervention are divided into: - Low Dose: 50 mcg of antigen with 250 mcg of Al(OH)3 - Median Dose: 100 mcg of antigen with 250 mcg of Al(OH)3 - High Dose: 100 mcg antien with 500 mcf of Al(OH)3 - Control (Placebo): 250 mcg of Al(OH)3 
INA-R2CYB06  Complete   Bioequivalence study of Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma in comparison with Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd. 
Interventions: The reference drug was the market available Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd, batch number AA1111 expiration date on February 2022. The test drug was Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma, batch number PEPYS002.01-01; manufacturing date on October 2021; expiration date on October 2023. 
INA-W48WO2  Complete   Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica in comparison with the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada) 
Interventions: Test drug : Cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica. Reference drug : Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada, Imported by PT Dexa Medica. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. 
INA-K8ARASK  Complete   Bioequivalence Study of Erlotinib 150 mg Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with Tarceva® 150mg Film-Coated Tablets Manufactured by Roche SpA, Segrate, Italy, Imported By PT. Boehringer Ingelheim Indonesia. 
Interventions: Subjects were given a single dose of 1 film-coated tablet of the drug (Erlotinib 150 mg film-coated tablets or Tarceva® 150 mg film-coated tablets) under fasted condition. The drug was administered with 240 mL water. 
INA-TPW9FSF  Complete   Implant 1 Batang Etonogestrel 
Interventions: Kesulitan dalam pencarian subjek yang bebas hormonal selama 3 bulan. 
INA-CY27H  Complete   BIOEQUIVALENCE STUDY OF NEBIVOLOL 5 MG TABLET PRODUCED BY PT YARINDO FARMATAMA IN COMPARISON WITH NEBILET (NEBIVOLOL 5 MG) TABLET MANUFACTURED BY BERLIN-CHEMIE AG, GERMANY, IMPORTED BY PT. MENARINI INDRIA LABORATORIES - INDONESIA 
Interventions: The reference drug was the market available Nebilet® 5 mg tablet produced by Berlin-Chemie AG, Germany, imported by PT. Menarini Indria Laboratories - Indonesia, batch number 02705B manufacturing date May 2020; expiration date May 2023. The test drug was Nebivolol 5 mg tablet produced by PT Yarindo Farmatama, batch number 13210621; manufacturing date June 2021; expiration date June 2023. 
INA-GYTE3LR  Recruit   Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018 
Interventions: Randomized, observer-blind, controlled, prospective intervention study. Test product: SARS-CoV-2 protein subunit recombinant vaccine, 2 doses 28 days interval, 0.5mL each dose Comparator: COVID-19 vaccine Bio Farma (inactivated vaccine), 2 doses 28 days interval, 0.5mL each dose 
INA-ZL7S4P  Recruit   Uji Diagnostik Alat Skrining Covid-19 berbasis Saliva "Gumnut/AptameX" 
Interventions: Penelitian ini menggunakan DNA aptamer berbasis point of core dengan dasar diagnostik yang lebih murah, cepat, dan akurat sebagai solusi skrining pada populasi yang terpajan virus COVID-19. DNA aptamer sequences akan berikatan dengan protein SARS-COV 2 yang mana telah di publikasikan tahun ini oleh 2 grup peneliti di China dengan menggunakan kit yang akan digunakan pada penelitian ini. DNA aptamer memanfaatkan struktur spektroskopi nano partikel yang bertransisi dari kondisi aggregasi dan disagregasi sebagai suatu sinyal transduksi mekanis pada kolorimetri ataupun lateral flow assays. 
INA-SN7GB2  Complete   BIOEQUIVALENCE STUDY OF CANDESARTAN CILEXETIL 8 MG + AMLODIPINE BESYLATE 5 MG TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH UNISIA® (CANDESARTAN CILEXETIL 8 MG + AMLODIPINE 5 MG) TABLET PRODUCED BY TAKEDA PHARMACEUTICAL COMPANY LTD., HIKARI, JAPAN 
Interventions: Test drug: Candesartan cilexetil 8 mg + Amlodipine besylate 5 mg tablet produced by PT Pratapa Nirmala Reference drug: Unisia® (Candesartan cilexetil 8 mg + Amlodipine 5 mg) tablet produced by Takeda Pharmaceutical Company Ltd., Hikari, Japan. 
INA-R99GO63  Recruit   Uji Klinis Suplementasi Probiotik pada Psoriasis Vulgaris 
Interventions: 1.Pada kelompok perlakuan diberi intervensi berupa pemberian terapi standard dan probiotik L.plantarum IS 10605 sejumlah 2x10pangkat10 CFU selama 12 minggu. 2.Pada kelompok plasebo diberi intervensi berupa pemberian terapi standard dan plasebo 2x1 sachet selama 12 minggu. 3.Mengukur derajat keparahan penyakit dengan Psoriasis Area and Severity Index (PASI), kadar serum sitokin TNF-α, IL-17, IL-10, dan Foxp3,serta memeriksa profil mikrobiota usus dari sampel feses sebelum dan sesudah perlakuan. 4.Kelompok kontrol sehat tidak diberi perlakuan. Dilakukan pengambilan sampel feses untuk pemeriksaan profil mikrobiota usus. 
INA-F7MRQNA  Recruit   A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older 
Interventions: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) dan Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) 
INA-HB8C9XD  Recruit   A global phase III clinical trial of recombinant COVID-19 vaccine (Sf9 cells) in adults aged 18 years and older 
Interventions: Recombinant COVID-19 vaccine (Sf9 cells) dan Plasebo 
INA-ZTGW21  Initial   A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia 
Interventions: This trial is observer blinded, comparative, randomized, phase I. Approximately 60 subjects will be recruited in this study. The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. The vaccine candidate (SARS-CoV-2 protein subunit recombinant vaccine) will be compared to active control. The regimen of the investigational product is 0.5 ml injected 50 μg in three dose-regimen (for all subjects) with 28 days apart between doses. Antibody testing after each dose will be conducted to evaluate the immunogenicity profile after vaccination. 
INA-TH0Z9M  Initial   Safety Profile of BCG vaccine vial (Bio Farma) 
Interventions: This trial is bridging study, observer blinded, comparative, randomized study. Approximately 220 subjects will be recruited, 110 subjects are the investigational arm (BCG vaccine vial) and 110 subjects are the active comparator arm (BCG vaccine ampoule). 
INA-FHLR49W  Initial   Bioequivalence study of Azithromycin 500 mg film coated caplets manufactured by PT Promedrahardjo Farmasi Industri in comparison with Azithromycin 500 mg Zithromax film coated tablets manufactured by PT Pfizer Indonesia; under licensed by Pfizer Inc, New York, N.Y., USA 
Interventions: Selambat-lambatnya 7 hari sebelum dan selama masa studi, subyek tidak diperbolehkan mengkonsumsi obat apapun, temasuk OTC, Suplemen kesehatan dan/atau jamu/Obat herbal. Dalam keadaan darurat, penggunaan obat non-studi harus dilaporkan (dosis dan waktu pemberian) kepada Dokter Penanggung Jawab. Merokok, alkohol dan makanan atau minuman yang mengandung xanthin, dan jus buah tidak diperbolehkan dalam waktu 24 jam sebelum dan selama seluruh hari pengambilan sampel pada setiap periode. 
INA-GO0HLGB  Initial   Immunogenicity and Safety Study of Half and Full Dose of Heterologous and Homologous COVID-19 Vaccine Booster in Adult Subjects in Indonesia 
Interventions: • Comirnaty® (Pfizer Vaccine) 0.3 ml intramuscularly • Comirnaty® (Pfizer Vaccine) 0.15 ml intramuscularly • ChAdOx1-S (AstraZeneca Vaccine) 0.5 ml intramuscularly • ChAdOx1-S (AstraZeneca Vaccine) 0.25 ml intramuscularly • CoronaVac® (Sinovac Vaccine) 0.5 ml intramuscularly 
INA-DC4CNNS  Complete   Modulasi Gut Microbiota dan Perbaikan Status Gizi pada Balita Gizi Kurang di Yogyakarta dengan Intervensi Jelly Candy Probiotik Lactobacillus plantarum Dad-13 
Interventions: Kelompok Probiotik : Permen jeli L. plantarum Dad-13 (Komposisi: gelatin sapi, sukrosa, glucose syrup, air, skim milk dengan L. plantarum Dad-13) Kelompok placebo: Permen jeli tanpa L. plantarum Dad-13 (Komposisi: gelatin sapi, sukrosa, glucose syrup, air, skim milk tanpa L. plantarum Dad-13 
XW2N3R  Initial   Vaksin Merah Putih UNAIR 
Interventions: UNAIR Inactivated COVID-19 Vaccine (Study Product) dan Sinovac – BioFarma COVID19 vaccine (Control) 2 dosis secara intramuscular selang 28 hari 
INA-KFQZKG  Complete   The Evaluation of the Effects of Implementing Tailored Care Program on Patients with Diabetes in Indonesia 
Interventions: The main study was a randomized controlled trial (RCT) to test and evaluate the tailored care for patients with diabetes in Indonesia. Design A single-blinded repeated measure RCT with two group pre-test and post-test design was used to test a tailored care intervention program for patients with diabetes in Indonesia. This design is particularly relevant where a new intervention as a tailored care program was compared to a routine treatment or a comparative intervention. Design for RCT is the gold standard to minimize bias through the process of random assignment and blinding. Moreover, the RCT as an intervention design was selected to test the effectiveness of the tailored care intervention. The intervention program is set at helping the participants acquire physiological outcomes, self-management, self-care activity, risk assessment for diabetes complications and psychosocial outcomes in three months of data collection after the intervention program. The main goals of the study were focused on after receiving three months tailored care program participant showed significant improvements from pre to post-intervention programs in improving the physiological outcomes (HbA1c, body mass index, blood pressure, triglyceride, blood glucose, triglyceride glucose index and cholesterol levels), diabetes self-management, self-care activity, risk assessment for diabetes complication, quality of life and diabetes-related distress. Randomization Lists of names of potential respondents who perform health checks routinely in primary health cares, have complete laboratory data especially HbA1c from September-December, are collected then randomized using a computer (Excel program) to avoid selection bias. After randomization, respondents were divided into two groups, intervention and control groups. Each address of respondent was also collected so, they could be tracked in each area where they lived. Furthermore, the researcher went to each respondent's house for inviting participant candidate to participate in the study. All respondents agreed to participate in the study because they would receive free medical tests such as blood sugar level, blood pressure, weight, height, cholesterol and triglycerides every month during the visit or follow up activity. Blinding In this study, all participants are blind to the allocation. It avoids those elements that have potentially influenced the outcomes from allocations. Participants were also blinded as to their group assignment to avoid their expectations for that treatment. It has been confirmed that there was no communication between participants in the intervention and the control group. The participants in control groups in this study receive d routine care from staff in a clinical setting. On the other hand, the intervention group received a tailored care program in the community setting. Preparation before tailored care program for diabetes implemented 1. Apperception related to all processes and procedures to be carried out in the study with two research assistants. 2. Research assistants attended an apperception about how to use the tailored care and practice skills for managing groups. 3. After apperception, facilitators were supported to deliver the intervention Application of the tailored care program for diabetes 1. Brief deducted teaching Firstly, it is necessary to hold a lay seminar attended by patients with diabetes. This seminar was filled with speakers who are experts in their fields such as a nurse, a doctor, and a nutritionist. The lay seminar contains ways for patients to perform self-management to maintain their blood glucose still stable while at home. 2. Assessment for self-management level and risk of cardiovascular disease (CVD) among patients After didactic teaching was completed, the nurse conducts an assessment to determine the level of patient self-management, how many the percentages of patients’ risk of complication. The risk report was personalized to describe individual complication risk then patients with a high risk of complications treated by the sub-specialist physicians. Patients were divided into groups for brainstorming the difficulties on glycaemic target and specific target behaviour. 3. Brainstorming among patients to share their difficulty on glycaemic targets and specific target behaviour Programs in the form of support groups between diabetes patients was a good media for patients to share their experiences with each other regarding their lifestyle for blood sugar control. This support group is accompanied by a facilitator to ensure information exchange among patients are still safe and there is no risk of malpractice when patients apply it themselves while at home. 4. Making a list of patients’ needs then rank the priorities The experience they gained from the discussion in the support group became their literature in choosing which invention was the most appropriate to keep their blood glucose stable while at home. 5. Setting a goal and writing action The goal of the patient that wanted to be achieved and the intervention plan that the patient has chosen can be written on a monitoring book that they have. Monitoring books can be read by health workers when patients with diabetes carry out health control routinely every month at primary health care. 6. Follow-up Each report in the monitoring book was valuable data for hospitals or health facilities to determine the most appropriate interventions for patients in the future. 7. Report of goals attempt After three months, participants report their goal attempt, where a goal has been partially achieved or not achieved. Moreover, the outcome evaluation (physical, self-management, psychosocial, self-care activity, risk assessment for diabetes complication) was also evaluated. 
INA-BZLNAF  Initial   Uji Klinik Fase III Acak Terbuka membandingkan Pemberian Terapi Tambahan Bamlanivimab - Etesivimab pada Standard of Care dibandingkan dengan Standard of Care Pada Pasien Covid -19 Derajat Ringan Sedang 
Interventions: Pemberian tamabahan antibodi monoklonal yaitu Bamlanivimab 700 mg dan Etesevimab 1400 mg dosis tunggal kepada Favipiravir 2 x 1600 mg hari pertama, dilanjutkan 2 x 600 mg sampai hari ke 5 dibandingkan saja dengan Favipiravir 2 x 1600 mg hari pertama, dilanjutkan 2 x 600 mg sampai hari ke 5 
INA-K4EBD14  Recruit   Uji Klinik Tocilizumab Balitbangkes - RS Dustira-UNJANI 
Interventions: Tocilizumab 8mg/kgBB selama 2 hari dan kelompok kontrol. 
INA-N8OBX96  Initial   Uji Klinik Tocilizumab Balitbangkes - RSUP Sardjito 
Interventions: Adjunctive Treatment of 8mg/kgBW atau 4mg/kgBW of Tocilizumab 
INA-ZAEQA4L  Initial   Riset Klinis Efikasi IVIG Balitbangkes-RS Kandou 
Interventions: Kel 1. Pengobatan Standard Covid-19 sesuai panduan praktek klinik COVID-19 RSUP Prof. dr. R.D. Kandou Kel 2. Pengobatan Standar + IVIG dosis 0,3 g/kgBB selama 3 hari Kel 3. Pengobatan Standar + IVIG dosis 0,5 g/kgBB selama 3 hari 
INA-K46P2P  Complete   PERBANDINGAN EFEK REMIFENTANIL INTRAVENA 1 µg/kgBB DENGAN 0,5 µg/kgBB DIIKUTI RUMATAN 0,1 µg/kgBB/MENIT TERHADAP PERUBAHAN TEKANAN DARAH DAN LAJU NADI SAAT INTUBASI ENDOTRAKEAL: UJI ACAK TERKENDALI 
Interventions: Subjek penelitian berjumlah 35 pasien yang terdiri dari kelompok remifentanil bolus 1 μg/kgBB (R1) dan kelompok remifentanil bolus 0,5 μg/kgBB (R2). Kelompok R1 diberikan remifentanil bolus 1 μg/kgBB, dilanjutkan rumatan 0,1 μg/kgBB/menit sebelum tindakan laringoskopi dan intubasi endotrakeal. Kelompok R2 diberikan remifentanil bolus 0,5 μg/kgBB, dilanjutkan rumatan 0,1 μg/kgBB/menit. Pemberian remifentanil bolus kedua kelompok dilakukan selama 60 detik, yang langsung dilanjutkan dengan dosis rumatan 0.1 μg/kgBB/menit menggunakan syringe pump. Selanjutnya diberikan propofol bolus 2 mg/kgBB selama 30 detik. Setelah tertidur, pasien diberikan atrakurium 0,5 mg/kgBB secara intravena. Jika laju nadi turun sampai < 40 x/menit, diberikan sulfas atropine 0,5 mg IV. Jika tekanan darah turun lebih dari 30%, diberikan vasopressor (ephedrine 5-10 mg). Rumatan anestesi menggunakan isofluran dan fraksi O2 dalam udara 50% dengan laju aliran 3 L/menit. Pengukuran hemodinamik mencakup tekanan darah sistolik, tekanan darah diastolik, dan laju nadi yang dilakukan 2 menit setelah induksi (T1), 1 menit setelah intubasi (T2), dan dilanjutkan pada menit ke 3 dan 5 setelah intubasi (T3 dan T4). Pendataan karakteristik demografi pasien mencakup usia, indeks massa tubuh dan status fisik ASA. 
INA-GDN05DZ  Recruit   International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE) 
Interventions: Tidak ada intervensi 
INA-QPSF79H  Complete   PERBANDINGAN PEMBERIAN FENTANYL 2 µg/KGBB BOLUS TUNGGAL DENGAN REMIFENTANIL 1 µg/KGBB SAAT INDUKSI DILANJUTKAN RUMATAN 0,1 µg/KGBB/MENIT TERHADAP KEJADIAN MUAL MUNTAH PASCABEDAH ODONTEKOMI 
Interventions: Pemberian fentanyl 2 µg/kgBB bolus tunggal dibandingkan dengan remifentanil 1 µg/kgBB saat induksi dilanjutkan dengan rumatan 0,1 µg/kgBB/menit pada kelompok 2 terhadap kejadian mual muntah pascabedah odontektomi. Pasien dibagi dalam dua kelompok, yaitu kelompok fentanyl 2 µg/kgBB bolus tunggal dan kelompok remifentanil 1 µg/kgBB diberikan saat induksi dilanjutkan rumatan 0,1 µg/kgBB/menit selama intraoperasi, masing-masing 22 sampel. Pada saat induksi anestesi umum diberikan 0,1 ml/kgBB dari obat yang sudah disediakan dalam spuit 10 ml menggunakan syringe pump dalam 1 menit dilanjutkan dengan propofol 2 mg/kgBB IV, atrakurium 0,5 mg/kgBB IV, kemudian dilakukan intubasi dengan pipa endotrakeal spiral. Untuk rumatan anestesi volatile sevofluran dan gas N2O : O2 50% dilanjutkan menggunakan obat yang telah disediakan dalam spuit 20 ml dengan rumatan 0,12 ml/kgBB/jam menggunakan alat syringe pump. Pasien diberikan antinyeri Parasetamol 20 mg/kgBB intravena 15 menit sebelum operasi selesai dan reverse diberikan antikolinesterase neostigmin. Selama operasi dilakukan pencatatan tekanan darah, nadi, saturasi oksigen. Pascabedah dilakukan pencatatan tekanan darah, nadi, saturasi oksigen, skala mual muntah. Pemantauan untuk kejadian mual muntah dilakukan observasional pencatatan setiap 30 menit dalam waktu 2 jam pascabedah di Ruangan Pemulihan. Untuk pasien yang mengalami kejadian mual muntah diberikan rescue Ondansentron 4 mg. 
INA-MCCLRWE  Recruit   Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia 
Interventions: N/A 
INA-D5T23Q7  Initial   UJI KLINIK JAMU SAMBILOTO PADA PASIEN COVID-19 2021 (UKIJASAMVID 2021) 
Interventions: METODE INTEVENSI: Uji klinik terkontrol acak tersamar ganda • Kelompok pembanding Subjek kelompok ini mendapatkan terapi standar untuk COVID-19 ditambah dengan plasebo dosis 3 x 4 kapsul setelah makan, berjarak 2 (dua) jam dari terapi standar. Intervensi dilakukan selama 10 hari atau sampai subjek sudah diperbolehkan pulang dari RS (jika kurang dari 10 hari). • Kelompok intervensi. Subjek mendapatkan terapi standar untuk COVID-19 ditambah dengan Jamu ekstrak sambiloto dosis 3 x 4 kapsul pagi dan sore setelah makan , berjarak 2 (dua) jam dari terapi standar. Jamu ekstrak sambiloto tersebut diberikan setiap hari selama 10 hari atau sampai subjek sudah diperbolehkan pulang dari RS (jika kurang dari 10 hari). Terapi standar untuk kasus sedang adalah obat yang digunakan untuk penderita Covid 19 gejala sedang yang berlaku di RSUD Bung Karno (sesuai PPK RSUD Bung Karno). BAHAN UJI: Jamu ekstrak sambiloto dan plasebo dibuat dan dikemas oleh PT. Industri Jamu Borobudur Indonesia. Jamu ekstrak sambiloto yang digunakan bermerk SAMBIO®. Sediaan jamu berupa kapsul berisi ekstrak sambiloto 330 mg. Kemasan berupa botol berisi 60 kapsul. Produk uji disimpan di gudang farmasi Rumah Sakit Bung Karno dengan suhu optimal yaitu kurang dari 25 derajat celcius dan di tempat yang kering. KONDISI SUBYEK: Pasien baru yang terdiagnosis Covid-19 dengan gejala sedang yang dirawat di instalasi rawat inap RSUD Bung Karno Surakarta 
INA-2SYO8K6  Recruit   Dexamethasone on Cerebral Toxoplasmosis Study (De-TOX Study) 
Interventions: Deksametason 20 mg (4cc) dibandingkan dengan plasebo (4 cc larutan NaCl 0.9%) selama 7 hari sebagai tambahan terapi antiparasit dan atau antiretroviral untuk pasien HIV dengan toxoplasma serebral. 
INA-EODLQCG  Initial   HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis 
Interventions: HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar. Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. 
INA-MY0NWNW  Initial   HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis 
Interventions: HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar. Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. 
INA-GTM5Y9O  Initial   HARVEST (Rifampisin oral dosis tinggi untuk memperbaiki luaran pada pasien dewasa dengan meningitis tuberkulosis 
Interventions: HARVEST merupakan uji klinik fase 3 terkontrol, multisenter, dan tersamar ganda yang bertujuan untuk menilai apakah rifampisin dosis tinggi dapat memperbaiki luaran 6 bulan dibandingkan dengan rifampisin dosis standar. Subyek akan dilakukan randomisasi 1:1 dan dibagi ke dalam dua kelompok: 1. Kelompok dengan rifampisin dosis tinggi (Rifampisin oral ~35 mg/kg/hari selama 8 minggu) dikombinasikan dengan standard HZE dan 2. Kelompok dengan rifampisin dosis standar (Rifampisin oral ~10 mg/kg/hari selama 8 minggu) dikombinasikan dengan standar dosis HZE. 
INA-AFXDQE9  Initial   Efikasi dan Keamanan Remdesivir pada Pasien COVID-19 Derajat Sedang-Berat di RSUP DR. M. Djamil Padang 
Interventions: Remdesivir selama 5 hari dosis Hari 1 200 mg dlm 500 cc Nacl 0,9%, hari 2-5 100 mg dlm 500 cc Nacl 0,9% VS kontrol (pengobatan tanpa anti virus) 
INA-HRAMP37  Initial   Studi Efikasi dan Keamanan Terapi IVIG pada Pasien Covid19 Derajat Berat di RSPI Prof. Dr. Sulianti Saroso 
Interventions: Standard of Care, Standard of Care + IVIG 
INA-GAXP9QZ  Initial   THE USE OF SYSTEMIC CORTICOSTEROIDS IN MODERATE TO CRITICAL ILL PATIENTS WITH COVID-19 
Interventions: Kelompok intervensi akan menerima perawatan standar dan terapi Dexamethason dengan dosis hari 1-2 3X4 mg, hari 3-4 2X4 mg, hari 5-6 1X4 mg segera setelah pengacakan. Kelompok pembanding akan menerima perawatan standar atau perawatan biasa dengan deksametason dosis 1x6mg hingga 10 hari. 
INA-QCMRCKG  Initial   Intravenous Immunoglobulin (IVIG) Sebagai Terapi Pasien Covid-19: Sebuah Uji Klinis 
Interventions: Terdapat lima kelompok perlakuan yaitu: 1. Kelompok 1 (kontrol): Terapi Standar 2. Kelompok 2: Terapi Standar + Dosis 0.3 g /Kg anti-COVID-19 IVIG selama 3 hari 3. Kelompok 3: Terapi Standar + Dosis 0.5 g /Kg anti-COVID-19 IVIG selama 3 hari 4. Kelompok 4: Terapi Standar + Dosis 0.3 g /Kg anti-COVID-19 IVIG selama 5 hari 5. Kelompok 5: Terapi Standar + Dosis 0.5 g /Kg anti-COVID-19 IVIG selama 5 hari 
INA-S4D4ZKN  Initial   COVID-REMISI 
Interventions: Kombinasi antar remdesivir dan plasebo atau remdesivir saja, diberikan sesuai kelompok atau arm randomisasi, sebagai berikut. Kelompok remdesivir durasi 10 hari Hari pertama : Loading dose remdesivir Hari ke 2-10 : Maintenance dose remdesivir Kelompok remdesivir durasi 5 hari Hari pertama : Loading dose remdesivir Hari ke 2-5 : Maintenance dose remdesivir Hari ke 6-10 : Plasebo 
INA-BDGYB4X  Recruit   Ivermectin Fase II-III 
Interventions: Fase II • Arm 1 : SoC + Ivermectin tablet dengan dosis 200 μg/kg sesuai dengan berat badan akan diberikan satu kali per hari, selama 5 hari. • Arm 2 : SoC + Ivermectin tablet dengan dosis 400 μg/kg sesuai dengan berat badan akan diberikan satu kali per hari, selama 5 hari. Fase III • Arm 1 : SoC + Ivermectin tablet selama 5 hari, dengan dosis yang aman berdasarkan uji klinik fase II. • Arm 2 : SoC + Plasebo yang identik dengan tablet Ivermectin sesuai dengan berat badan akan diberikan satu kali per hari, selama 5 hari. 
INA-EKR2903  Initial   NA 
Interventions: - Semua subjek akan berpuasa selama 10 jam semalam (09.00 - 07.00) sebelum pemberian obat. Tidak ada asupan makanan khusus yang dirancang untuk penelitian ini. Asupan air akan diizinkan sesuai keinginan kecuali selama 1 jam (jam) sebelum pemberian obat studi dan 2 jam setelahnya. Setelah titik-titik ini, air hangat akan disediakan sesuai keinginan. Tidak ada makanan yang diizinkan sampai 4 jam setelah pemberian obat studi. Makanan standar akan disajikan pada 4 jam (sarapan), 6 jam (makan siang), dan 12 jam (makan malam) setelah pemberian obat studi. - Setelah puasa semalaman, kira-kira pukul 06.00 pada hari pengambilan sampel, diambil 5 ml sampel darah pre-dose dalam waktu satu jam sebelum pemberian obat untuk setiap periode. Setelah pemberian obat, sampel darah 5 ml akan diambil pada waktu pemberian obat 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 9, 12, 16 dan 24 jam - Subjek harus tetap dalam posisi berbaring sampai periode 4 jam setelah pemberian obat. Subjek tidak akan diizinkan untuk keluar dari fasilitas klinis kecuali atas izin dokter yang bertanggung jawab. - Pemantauan tanda vital (body temperature, blood pressure, heart rate/pulse rate and, respiration rate): predose, 1, 2, 4, 6, 9, 12, 24 dan 32 jam setelah pemberian obat. 
INA-XH6BCFP  Initial   Serological screening and treatment to prevent recurrence of tertian malaria (SSAT STUDY) 
Interventions: Uji coba terkontrol secara acak dengan skrining serologis dan pengobatan sebagai intervensi. Anak sekolah terpilih akan dialokasikan ke dalam dua kelompok studi: (1) skrining dan pengobatan serologis (SSAT), dan (2) kelompok kontrol. 
INA-CLYNAA  Initial   Seroprevalence of Hepatitis A in Indonesia part of "Seroprevalence of Hepatitis A in 3 South East Asian Countries: Indonesia, The Philippines And Vietnam" 
Interventions: This is study without intervention 
INA-R8NGMEW  Initial   The Effect of Incremental Continous Ambulatory Peritoneal Dialysis on the Preservation of Residual Kidney Function and Clinical Outcomes: A Randomized Controlled Trial 
Interventions: CAPD patients will be screened according to the examination results of baseline eGFR and 24-hour urine volume. Patients with significant Residual Kidney Function will be assigned as potential subject in this study and screened based on the inclusion and exclusion criteria. The significant Residual Kidney Function is defined as if a patient has minimum urine volume of 400 ml/day and residual eGFR minimum of: - 6 mL/min/1.73 m2 for body weight 40-55 kg - 8 mL/min/1.73 m2 for body weight 55.1-73 kg - 9 mL/min/1.73 m2 for body weight 73.1-91 kg - 10 mL/min/1.73 m2 for body weight 91.1-109 kg Subjects who agree to join this study will undergo physical examination and laboratory tests (hemoglobin, ureum, creatinine, calcium, phosphate, albumin, serum iron, TIBC, ferritin, CRP, electrolyte, and peritoneal equilibration test) as baseline data; assigned as data at day-0. In addition, they will fill out the KDQOL-SFTM 1.3 questionnaire for baseline QoL data. They will be randomly assigned to intervention or control group in a 1:1 ratio using block randomization. Subjects in intervention group (Group A) will receive 1 cycle of Icodextrin with 8-12 hours dwell time at night and 2 cycles of Dianeal with dwell time 4-6 hours per day. Subjects in control group (Group B) will be receive 4 cycles of Dianeal per day with dwell time 4-6 hours each. Concentration of the glucose prescribed will be decided by the clinician based on volume status, urine production, and daily ultrafiltration. Subjects will be assessed in three months trial. The assessment for primary and secondary outcomes will be held at day-30, 60, and 90. 
INA-WXPBFS9  Initial   NA 
Interventions: 1. Kurang lebih 1 jam sebelum pemberian obat, subjek harus mandi sebelum menjalani pemeriksaan fisik untuk data tanda vital awal (suhu tubuh, tekanan darah, detak jantung / nadi, dan laju respirasi). Subjek wanita usia subur harus menjalani tes kehamilan. Data tersebut akan dicatat di CRF. 2. Keesokan paginya, sebelum obat diberikan ke subjek, botol harus dibuka. Untuk Obat Uji: tambahkan volume total 19 mL air yang dibagi menjadi 2 bagian. Untuk Obat Referensi: tambahkan volume total 20 mL air dibagi menjadi 2 bagian. Kemudian obatnya harus dikocok dengan baik setidaknya selama 30 detik pada setiap penambahan air. 3. Obat harus dikocok dengan baik sampai homogen sebelum diberikan kepada subyek. Sesuai jadwal, pengambilan sampel mulai pukul 07.00 pagi hari, subjek akan diberikan dosis tunggal 5 ml Cefixime Sirup Kering untuk kedua formulasi (obat uji dan pembanding) dengan ujung kateter jarum suntik dalam posisi duduk. Setiap subjek akan diberikan air sebanyak 240 ml. Kemudian ujung kateter jarum suntik harus dibilas minimal 3 kali dengan air. Subjek diminta diminta untuk menelan semua air yang tersisa. Kemudian subjek diminta untuk dalam posisi tegak (berdiri atau duduk) selama 1 jam setelah pemberian dosis. 
INA-K7QXEST  Complete   The effect of Consumption Lactococcus lactis Subsp. Cremoris Probiotics on Gut Microbiota, Food Intake and Defaecation in Indonesian Women with Constipation 
Interventions: The dietary supplements used in this study were hard capsules containing Lc. cremoris FC (1 X 107 cfu; 2 X 107 cfu) and a placebo. Each daily dose comprised two capsules, with hot/cold water per a day within 30 minutes after dinner during intake. 
INA-HOZ2FWH  Initial   Randomised Evaluation of Covid-19 Therapy (RECOVERY) 
Interventions: RECOVERY merupakan uji coba label terbuka dan acak pada pasien yang dirawat di rumah sakit karena COVID-19. Desain faktorial digunakan sehingga subyek yang memenuhi syarat dan setuju ikut serta dalam penelitian dapat diacak/dirandomisasi ke salah satu kelompok randomisasi utama, yaitu: (Pengacakan Utama bagian A pada protokol) • Perawatan rutin tanpa tambahan pengobatan • Kolkisin 500 mg (oral atau nasogastric tube) atau intravena 1x/hari selama 10 hari atau kelompok Pengacakan Utama bagian C: • Perawatan rutin tanpa tambahan pengobatan • Aspirin 150 mg (oral atau nasogastric tube) atau per rektal 1x/hari hingga pasien keluar rumah sakit. Jika kondisi subyek semakin berat dan memenuhi syarat, maka dilakukan pengacakan kedua atau lanjuta antara kelompok pengobatan berikut: • Tidak ada pengobatan/terapi tambahan • Tocilizumab, melalui pemberian infus intravena dengan dosis ditentukan berdasarkan berat badan sebagai berikut: - 40 dan ≤65 kg = 400 mg - 65 dan ≤90 kg = 600 mg - > 90 kg = 800 mg Catatan: berat badan dapat diperkirakan jika menimbang pasien tidak praktis Tocilizumab harus diberikan sebagai infus intravena tunggal selama 60 menit dalam 100ml natrium klorida 0,9%. Dosis kedua dapat diberikan ≥12 dan  
INA-NEB8Z5Y  Recruit   Novel Coronavirus Vaccine (CHO cell) Phase III clinical trial 
Interventions: Investigational Vaccine: ZF2001 Name : Recombinant Novel Coronavirus Vaccine (CHO cell) Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Specifications : 0.5ml/vial. It contains 25 μg NCP-RBD protein Ingredients : NCP-RBD, Aluminum Hydroxide Adjuvant Dosage form : injection The injection way: intramuscular injection of deltoid muscle of upper arm Vaccination dose: 0.5ml Vaccination schedule: 0,1,2 months Placebo: Name : Novel Coronavirus Vaccine (CHO cell) placebo (with aluminum) Manufacturer : Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Specifications : 0.5 ml/vial. It contains 0.25mg aluminum hydroxide adjuvant Ingredients : Aluminum hydroxide adjuvant Dosage form : injection The injection way: intramuscular injection of deltoid muscle of upper arm Vaccination dose: 0.5ml Vaccination schedule: 0,1,2 months 
INA-NT3BFHA  Recruit   Uji klinik (2R2): Dosis Tinggi Rifampisin versus Dosis Standar Rifampisin untuk Pengobatan Infeksi Laten TB (ILTB) 
Interventions: Berdasarkan panduan WHO yang telah menerbitkan rekomendasi terbaru untuk pengobatan ILTB dengan regimen Rifampisin selama 4 bulan (4R). Pada uji klinik ini kami berencana untuk memverifikasi bahwa monoterapi Rifampisin dosis lebih tinggi (20 mg/kg dan 30 mg/kg) memiliki kemanjuran yang sama dengan 4R, tanpa ada peningkatan efek samping serta aman; karena pengobatan ILTB menyiratkan pengobatan terhadap orang sehat. Uji klinik ini merupakan fase 2b, dan apabila dari uji klinik ini didapatkan bukti (evidence) baru, maka selanjutnya akan diteruskan ke uji klinik fase 3 yang melibatkan lebih banyak negara dengan jumlah subjek yang lebih banyak. Untuk itu Intervensi yang dilakukan terhadap subyek pada uji klinik ini yaitu memberikan obat regimen Rifampisin dengan dosis harian tinggi yakni 20 mg/kg dan 30 mg/kg. Yang memiliki tujuan serta manfaat seperti berikut: Tujuan utama: Penyelesaian pengobatan: Membandingkan penyelesaian pengobatan tiga regimen rifampisin oral harian dengan dosis berbeda: (1) dosis standar = 10 mg/kg/hari selama 4 bulan (4R10), atau (2) dosis tinggi 20mg/kg/hari selama 2 bulan (2R20), atau, (3) dosis tinggi 30 mg/kg/hari selama 2 bulan (2R30). Penyelesaian akan didefinisikan sebagai menyelesaikan pengobatan setidaknya 90% dari dosis dalam 120% dari waktu yang diizinkan (54 dosis dalam 72 hari untuk regimen dosis tinggi 2 bulan dan 108 dosis dalam 144 hari untuk regimen standar). Keamanan: Membandingkan efek samping tingkat 3-5 dari tiga regimen yang mengakibatkan penghentian obat studi secara permanen dan dianggap mungkin atau mungkin terkait dengan obat yang diteliti (penilaian apakah efek samping tersebut dilakukan oleh tim independen yang beranggotakan 3 orang yang tidak mengetahui ketiga regimen tersebut)). Tujuan sekunder: Membandingkan efek samping tingkat 1-2 dari tiga regimen yang mengakibatkan penghentian obat studi secara permanen dan dianggap mungkin atau mungkin terkait dengan obat yang diteliti oleh tim independen yang tidak mengetahui ketiga regimen tersebut (keamanan). Membandingkan tiga regimen dalam hal kejadian TB aktif dalam 26 bulan setelah pengacakan (kemanjuran). Manfaat Penelitian: Beberapa manfaat yang dapat diperoleh dari penelitian ini, antara lain: Bila terbukti penyelesaian pengobatan lebih baik dan keamanan dari regimen dosis tinggi sama baiknya dengan dosis tinggi, maka pengobatan ILTB dapat menjadi lebih singkat, hanya 2 bulan. Subjek yang diikutsertakan dalam penelitian mendapatkan pemeriksaan skrining ILTB, pemantauan dan pemeriksaan berkala selama 26 bulan sejak dirandomisasi. Subjek yang diikutsertakan dalam penelitian mendapatkan pengobatan ILTB yang bebas biaya. 
IINA-HWO0848  Initial   Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children, and Infants 
Interventions: Blood sampling at 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, children and infants groups in subject Phase II clinical trial. One dose Vi-DT vaccine in subject aged 6-23 months when receiving the primary dose. 
IINA-LWE89BE  Initial   Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia 
Interventions: This is Observational study without intervention 
INA-78S909M  Complete   The effects of a probiotic milk drink, Yakult®, containing Lactobacillus casei Shirota on the intestinal microbiota and intestinal environment in residents and staff at elderly houses in Indonesia 
Interventions: Intervention Group : Yakult®: Fermented milk drink containing over 6.5×109 CFUs of L. casei Shirota/65 ml, 1 bottle/day for 24 weeks (168 days). Placebo Group : Placebo: Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product. 1 bottle/day for 24 weeks (168 days). 
INA-XSPZF53  Recruit   Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies 
Interventions: This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults. 
INA-TZ0XXFY  Initial   The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and astaxanthin 6 mg tablet once daily (experimental group) 
INA-LYY8GNT  Initial   The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin B combination (vitamin B1 100 mg, vitamin B6 200 mg, and vitamin B12 200 mcg) once daily (experimental group) 
INA-MEODDY6  Initial   The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient 
Interventions: This is a randomized clinical trial, active comparator, open label, controlled study. Eligible subjects were randomly allocated to receive any of the following regiments: standard therapy consists of pregabalin, gabapentine, or amitriptyline (control group) or standard therapy and vitamin D 5000 IU tablet once daily (experimental group) 
INA-PA2HB87  Complete   Effects of Dietary Intake and Supplementation of Indigenous Probiotic Lactobacillus plantarum Dad-13 on Body Mass Index, Faecal Short-Chain Fatty Acid, and Gut microbiota of Undernourished Children in East Lombok, Indonesia 
Interventions: Probiotic powder "ProbioGama" with probiotics Lactobacillus plantarum Dad-13 with viability 10^9 CFU/gram. 40 Subject divided into 2 groups : - Probiotic Group : Consume Probiotic Powder ProbioGama 1 sachet/ Day (1 sachet = 1 gram) - Plasebo group : consume skim milk powder 1 sachet (1 sachet = 1 gram) 
INA-2A8RG4R  Complete   PENGARUH KONSUMSI PROBIOTIK POWDER INDIGENOUS DALAM MENYEHATKAN SALURAN PENCERNAAN PADA PENDERITA OBESITAS 
Interventions: Intervensi Produk Probiotik Powder dengan viabilitas 10^9 CFU/Gram/Hari pada kelompok probiotik 
INA-N9A8PM2  Initial   Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) 
Interventions: • Drug: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) • Other: Placebo • Drug: Remdesivir 
INA-K2SGZ24  Initial   NA 
Interventions: 1. Sekitar 1 jam sebelum pemberian obat, subjek menjalani pemeriksaan fisik untuk data tanda vital awal (suhu tubuh, tekanan darah, denyut jantung / nadi, dan laju pernapasan). Subjek perempuan usia subur harus menjalani tes kehamilan urin. 2. Pada pukul 07:00 pagi, dosis oral tunggal 150 mg Pregabalin diberikan pada masing-masing subjek dengan 240 mL air dalam posisi duduk. 3. Subjek harus tetap dalam posisi duduk sampai periode 1 jam setelah pemberian obat. 4. Pemantauan tanda vital (body temperature, blood pressure, heart rate/pulse rate and, respiration rate): predose, 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat. Subjek diinstruksikan untuk menginap satu malam sebelum dan selama periode pengambilan sampel setidaknya selama 24 jam setelah pemberian obat - Subjek diinstruksikan untuk berpuasa dari 8 jam sebelum sampai dengan 4 jam setelah obat administrasi - Menu yang disajikan dan makanan yang diambil oleh subjek distandarisasi dan dicatat - Air dapat dikonsumsi sesuai keinginan kecuali selama jangka waktu 1 jam sebelumnya sampai 2 jam setelah pemberian obat - Tanda-tanda vital (tekanan darah, nadi, laju respirasi dan suhu tubuh) adalah dipantau dan dicatat sebelum pemberian obat, dan selanjutnya pada 1, 2, 3, 4, 12, 24 dan 36 jam setelah pemberian obat. Keamanan subjek dipantau selama seluruh studi di bawah pengawasan langsung oleh Pelajari Dokter di lokasi penelitian. 
INA-1M7KY9N  Initial   Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference with Co-Administered EPI Vaccines (Phase III) 
Interventions: Investigational product: Rotavirus RV3 Vaccine (Bio Farma); Control product: Placebo 
INA-2GHFOKN  Initial   International SARS-CoV-2 Infection Observational Study (ICOS) 
Interventions: Tidak ada Intervensi 
INA-BB6K0Q7  Initial   Reducing the risk of Plasmodium vivax relapse after acute Plasmodium falciparum malaria in co-endemic areas - a randomized controlled trial (PRIMA STUDY) 
Interventions: Uji klinis terbuka, acak terkontrol dengan dua arm pada penderita P. falciparum, yaitu: i. Kelompok intervensi dengan pengobatan tambahan untuk P. vivax ii.Kelompok kontrol tanpa pengobatan tambahan untuk P. vivax 
INA-H9QLN22  Recruit   Fase III, Acak-terbuka, Uji Klinik Efikasi dan Keamanan Favipiravir pada Pasien Covid-19 di Indonesia 
Interventions: Pemberian obat Uji dan Komparator Obat Uji Hari 1: Favipiravir 2 x 1600 mg (8 tablet), Hari 2 sampai hari ke 7 hingga maksimal 14 hari : Favipiravir 2 x 600 mg (3 tablet) sehari, + Azithromycin 1 x 500/hari selama 5 hari Komparator : + Azithromycin 1 x 500/hari selama 5 hari 
INA-HL5Q9B1  Initial   PlaSenTer 
Interventions: Plasma Convalescet @200mL, 2x pemberian dengan jangka waktu 3 hari 
INA-6E2YX0X  Recruit   Solidarity Trial 
Interventions: Local standard of care alone, OR local standard of care plus one of • Remdesivir (daily infusion for 10 days) • Chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days) • Lopinavir with Ritonavir (orally twice daily for 14 days) • Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days). 
INA-TX6YYSS  Complete   Uji Klinis Fase III, Multisenter, Acak Terkontrol, Tersamar Ganda Membandingkan Efikasi Dan Keamanan Kombinasi Baru Lopinavir/Ritonavir-Azithromycin, Lopinavir/Ritonavir-Doxycycline, Serta Hydroxychloroquine-Azithromycin Dengan Obat Standar Pada Pasien COVID-19 Yang Dirawat Di Rumah Sakit Dengan Derajat Ringan, Sedang, Dan Berat Yang Tidak Menggunakan Ventilator 
Interventions: Pasien positif COVID-19 yang dibuktikan dengan hasil PCR dan memenuhi kriteria inklusi serta eksklusi pada penelitian ini diberikan obat uji klinik selama 7-14 hari. Selama penelitian dilakukan evaluasi: 1. Evaluasi laboratorium (pemeriksaan darah lengkap, fungsi liver, fungsi ginjal, CRP, D-dimer, elektrolit) pada H-1 dan H-7. 2. Pemeriksaan EKG setiap hari 3. Pemeriksaan Rontgen Dada H-1, H-7, dan H-14, 4. Pemeriksaan PCR Kualitatif dan Kuantitatif (Jumlah Copy Virus) pada H-1, H-3, dan H-7. 5. Pemeriksaan Sitokin pada H-1 dan H-7. 
INA-QCA4OWA  Initial   Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients: Randomized, Double-blind, and Placebo-controlled 
Interventions: Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 107cells of DW-MSC for the low-dose group or 1 x 108cells for the high-dose group after registration. 
INA-WXFM0YX  Initial   A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia 
Interventions: Investigational product: SARS-CoV-2 vaccine (inactivated) Control product: placebo 
INA-1LX0O6E  Recruit   KAPSUL EKSTRAK ETANOL 70% TERFRAKSINASI DAUN J. gendarussa Burm. f SEBAGAI OBAT KB PRIA 
Interventions: Subyek akan diminta untuk minum dua kapsul ekstrak dengan dosis 450 mg ekstrak etanol 70% terfraksinasi daun J. gendarussa atau plasebo satu kali sehari, selama 12 bulan. Pada masa subur istri, pasangan diminta untuk melakukan hubungan seksual. Pasangan akan diamati selama 12 bulan masa masa minum obat, yang dilanjutkan dengan pengamatan reversibilitas 72 hari setelah putus obat, sesuai dengan lamanya proses spermatogenesis. 
INA-QXZNETK  Initial   Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV) 
Interventions: The study is a double-blind, randomised, placebo-controlled trial that will be conducted in healthcare settings. After obtaining fully informed consent, we will recruit healthcare workers, or other individuals at significant risk, who can be followed up reliably for up to 5 months. In Asia they will be randomised to receive either chloroquine or placebo (1:1 randomisation). In Europe they will be randomised to receive either hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10 mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days). 
INA-EW74C1N  Recruit   The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients 
Interventions: Intervention divided into 3 group; Group 1 : Alveolar cleft repair (gnatoplasty) with Poly-P as bone substitute, Group 2 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Poly-P as bone substitute, Group 3 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Microfragmented fat (MFAT) as bone substitute. 
INA-KGMRF0T  Initial   Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants 
Interventions: Investigational product: DTP-HB-Hib Vaccine (Bio Farma) using different source of Hepatitis B bulk and Recombinant Hepatitis B (Bio Farma) using different source bulk Control Product: Pentabio Vaccine® (Bio Farma) and Recombinant Hepatitis B® vaccine (Bio Farma) 
INA-HETTL12  Recruit   D2EFT 
Interventions: Yes: Dolutegravir, Darunavir, Ritonavir 
INA-OL70Y5G  Complete   Integrasi Kesehatan Jiwa di Klinik HIV untuk Meningkatkan Keberhasilan Pengobatan Antiretroviral: Skrining Gangguan Depresi pada Orang Dengan HIV di Rumah Sakit 
Interventions: Tidak ada intervensi 
INA-WHMG3FX  Initial   The Benefit of Add on Vitamin D or Vitamin B combination or Either for Painful Diabetic Neuropathy 
Interventions: Add on vitamin D (400 IU) per day to standard treatment (pregabalin, gabapentin, or amitryptilin) 
INA-MZXONZG  Initial   Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to lot consistency, Non-inferiority to PQed TCV and Typhoid Vi Polysaccharide Vaccine 
Interventions: Vaksin Tifoid Konjugat (Vi-DT) 
INA-53EA9LH  Initial   The role of DLBS1033 in the management of acute ischemic stroke patients: study protocol for a randomized controlled study 
Interventions: This is a randomized controlled open label trial. There will be 2 groups in this study, group 1 consists of subjects treated with DLBS1033 + standard therapy of ischemic stroke, whereas group 2 consists of subjects treated with placebo of DLBS1033 + standard therapy of ischemic stroke. DLBS1033 and placebo of DLBS1033 will be given 2 tablets three times per day for 30 days. 
INA-F3KQ3DK  Initial   Comparison of Intravenous Ibuprofen and Ketorolac for Acute Musculoskeletal Pain from Various Etiologies 
Interventions: This is a quasi experimental, non randomized, non equivalent, active comparator, open label study. The intervention in this study is an intravenous 800 mg ibuprofen. The intravenous ibuprofen will be given every 12 hours. We will need 4 intravenous ibuprofen injection for every patient. There will be a total need of 120 IV ibuprofen injection for this study. The control in this study is an intravenous 30 mg ketorolac. The ketorolac injection will be given every 12 hours. 
INA-FBT1T7P  Initial   Evaluasi Ekonomi Intervensi Koroner Perkutan pada Pasien Angina Pektoris Stabil dan Sindrom Koroner Akut di Indonesia 
Interventions: Penelitian ini tidak melakukan intervensi kepada subjek. 
INA-DPS3T9B  Initial   Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children 
Interventions: Investigational Product Recombinant Hepatitis B (Bio Farma) Vaccine Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660318UK Expiry Date September 2020 Active Comparator Recombinant Hepatitis B (Bio Farma) Vaccine® Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660718 Expiry Date 31 August 2020 
INA-OB1RAKC  Initial   A Comparison Between Non-steroid Anti-inflammatory Drugs and Its Combination with Eperisone hydrochloride in Acute Non-Spesific Back Pain 
Interventions: There are 2 groups of subjects. First group will receive a combination of eperisone hydrochloride and ibuprofen, whereas second group will only receive ibuprofen. We use 50 mg of eperisone hydrochloride taken three times per day and 400 mg of ibuprofen taken two times per day. Each medication must be taken every day for 4 weeks. Each subject will also receive 500 mg of paracetamol as a rescue medication. 
INA-0BD1YLW  Initial   Immunogenicity & Safety of Bio Farma’s Measles-Rubella (MR) Vaccine in Indonesian Infants 
Interventions: IP: Vaksin Measle - Rubella (MR) Biofarma Active Comparator: Vaksin Measle Rubella (MR) SII 
INA-55NX6PA  Initial   Protectivity and Safety Following Recombinant Hepatitis B Vaccine 
Interventions: 3 doses of Recombinant Hepatitis B 
INA-ZN6M5MG  Initial   Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria 
Interventions: Sanaria® PfSPZ Vaccine: Radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) administered by direct venous inoculation (DVI). Normal Saline (0.9% NaCl): The placebo control administered by DVI. Sanaria® PfSPZ-CVac: Infectious, aseptic, purified, cryopreserved PfSPZ (Sanaria® PfSPZ Challenge) administered by DVI to individuals taking chloroquine (CQ) chemoprophylaxis. Normal Saline (0.9% NaCl): The placebo control administered by DVI to individuals taking CQ chemoprophylaxis. Diluent. The diluent for PfSPZ Vaccine and PfSPZ Challenge will be phosphate buffered saline (PBS) with 1% human serum albumin. 
INA-0BBB401  Initial   INA105 - SchisCCA 
Interventions: N/A 
INA-DTPL801  Initial   START Study 
Interventions: Investigational product: - Product: Deferiprone oral solution 80 mg/mL - Dose: 25, 50, or 75 mg/kg/day, divided t.i.d. - Mode of administration: Oral Reference product: - Product: Placebo - Dose: Volume of solution matching that required for a 25, 50, or 75 mg/kg/day dose of active product, divided t.i.d. - Mode of administration: Oral 
INA-Z7X0Q5P  Recruit   Pengaruh penambahan kurkumin pada pasien mieloma multipel 
Interventions: Kurkumin 8 gram/hari selama 4 bulan 
INA-N910C51  Complete   Comparative Study of Efficacy and Safety Lynestrenol versus Exluton® in Women of Childbearing Age 
Interventions: This is a prospective, randomized, open label, comparative, parallel study to evaluate efficacy and safety of 0.5 mg lynestrenol during 12 months of drug administration. The randomization code is tabulated for all subjects according to block randomization with a block size of 4 (Dixon & Massey, 1969, p 447). The study will be conducted in PT Equilab International as the study center in collaboration with some midwife clinics in Jakarta and surrounding areas. The data of pregnancy occurrence will be evaluated by urine HCG test every 2 months at until 12 months of evaluation period. The data of adverse events occurred during the study will be collected based on subject’s diary, anamnesis, and medical examination. Subjects are not allowed to use other contraception except the investigational product (0.5 mg Lynestrenol that dispensed from the study site) 
INA-8EAHA56  Complete   Studi Efektivitas Monoplant® dibandingkan dengan Indoplant® 
Interventions: Studi ini merupakan uji klinik fase III, ‘terbuka’ (‘open label’ Randomized Clinical Trial), dilakukan randomisasi serta multisenter, dengan membandingkan dua macam susuk KB yaitu Monoplant® dan Indoplant® yang dilakukan pada wanita sehat Indonesia. Blok random alokasi persepuluhan dan ditetapkan secara random dibagi 5 Monoplant dan 5 Indoplant. Total sampel yang akan diamati dalam studi ini: 450 subjek wanita pemakai Monoplant® dan 450 subjek wanita pemakai Indoplant® di 5 (lima) senter di Indonesia, yaitu Jakarta, Semarang, Surabaya, Palembang dan Makassar. Tiap senter akan merekrut lebih kurang 180 subjek (90 akseptor Monoplant dan 90 akseptor Indoplant), untuk kedua jenis susuk KB ini tergantung dari kemampuan dan kesanggupan senter merekrut sampelnya. Pengamatan terhadap subjek dilakukan selama 3 tahun. Pengambilan darah untuk pemeriksaan kadar LNG dilakukan subsampel (33 subjek) untuk masing-masing susuk KB Monoplant dan Indoplant, khususnya pada subjek di senter Jakarta. Pemeriksaan kadar LNG dalam darah dilakukan di PT. Equilab Internasional. 
INA-P1WG34P  Recruit   INA-PROACTIVE 
Interventions: No Intervention 
INA-LML8DP8  Complete   Profil Keamanan Vaksin Td (Bio Farma) pada Ibu Hamil di Indonesia 
Interventions:
INA-2FRR4L5  Initial   Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I) 
Interventions: Adult&Children: One dose of Rotavirus Vaccine Neonates: Three doses of Rotavirus Vaccine 
INA-BCER292  Complete   Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children 
Interventions: 1 dose Measles Rubella (MR) vaccine 
INA-3PTS6EX  Complete   Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population 
Interventions: 9-40 years old: 1 dose of Quadrivalent Influenza Vaccine 6 months - 8 years old: 2 dose of Quadrivalent Influenza Vaccine 
INA-35ST1PS  Initial   Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II) 
Interventions: 1 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine 
INA-AB1DBOS  Complete   Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I) 
Interventions: 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine 
INA-C273S0L  Complete   Immunogenicity and Safety Profile of Primary Dose of bivalent OPV (bOPV Bio Farma) Given Simultaneously with Pentabio® and Inactivated poliovirus vaccine (IPV) at the 4th Visit in Indonesian Infants 
Interventions: bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule. 
INA-H9W8EPN  Recruit   TT063 STUDY 
Interventions: The following 2 groups are examined. The subjects are randomly allocated to these groups at the ratio of 1:1. SFPP group: One patch of SFPP is applied to the assessed knee once daily. Diclofenac (DC) group: Two gram of diclofenac gel per application is applied to the assessed knee 4 times daily. Pre-treatment Drugs: Patients take celecoxib 200 mg per day prescribed by investigator from screening visit (1st visit) to washout visit (2nd visit) as the pre-treatment for knee OA. Rescue Drugs: Use of paracetamol 1,000 mg once daily as the rescue drugs for knee pain is permitted from washout visit (2nd visit) to the end of final tests and observation only when the subjects cannot tolerate their knee pain (ex. they cannot rise up from chair). [Exception] Rescue drugs cannot be used within two days before the scheduled site visits. 
INA-7GNRTO6  Recruit   Tuberculosis Research of INA-RESPOND On Drug Resistance 
Interventions: Tidak ada Intervensi; Observational 
INA-PLE3XOP  Recruit   Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia. 
Interventions: Not Applicable, this is observational study 
INA-ODE8ELW  Complete   S-Collate 
Interventions: All clinical information and laboratory parameters documented for this observational study prior to start of PEG IFN treatment and during this study were routinely assessed as SOC and not for the purpose of this study. Patient’s medical history, demographics, and disease characteristics were extracted from the medical record, as well as the CHB treatment observations (dose and exposure), concomitant medication and AEs. To evaluate serological and virological treatment response the respective tests were done as routine procedures, test kits and frequency of measuring depending on SOC in the respective clinic/practice. Patients were observed for the duration of PEG IFN treatment and for up to 3 years afterwards. 
INA-XL122KL  Complete   FastAct II 
Interventions: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. 
INA-4Q9Y8KM  Complete   ActUp 
Interventions: This is a 6-month non-interventional, observational, post-marketing, multi-center and local study in RA patients, who are currently being treated with tocilizumab. This study is observational therefore no additional visits will be required, no study-specific medication will be administered and no other interventional procedures additional to those comprising routine clinical practice will be performed. The co-morbidities of patients meeting all selection criteria will be reviewed and patients will be followed-up over a 6-month observation period. Since patients have initiated treatment prior to study start-up, data collection is partially retrospective. Data collection will include the following sources: - Patients’ co-morbidities. - Data recorded by the principal investigator and collaborators during the routine visits of the patient. Since the study is observational, the visits are those pre-scheduled as part of usual clinical practice. These include: - One enrolment visit (this visit may occur up to 8 weeks after the first tocilizumab treatment, and in this case data collection will be retrospectively collected up to the first tocilizumab treatment). - Usual follow-up visits according to the center’s practice, which will take place during the study observation period up to 6 months after tocilizumab treatment initiation. - One final visit, corresponding to that performed nearest to 6 months after tocilizumab treatment initiation. Additional tests for the recruited patients are not foreseen, since this is an observational study. The doses and duration of treatment will be stipulated by the Investigator, according to local guidelines and/or routine clinical practice. No study-specific drug will be administered. The dose and duration of treatment before, during, and after the study will be based upon the Investigator’s judgment and in accordance with the label and local regulations. Tocilizumab administration may occur as per routine practice and following the local label. Treatment-related information (including efficacy and safety information, where available) may be collected at the same time-points as tocilizimab administration, but will be at the discretion of the investigator in line with local routine practice. The study population will include patients with moderate to severe RA, according to ACR criteria [13] and DAS28 joint scores [43], in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label). This can include patients who have received tocilizumab treatment within 8 weeks prior to the enrollment visit. Furthermore, patients must have given their informed consent and must not meet any of the exclusion criteria 
INA-P0Q2OY0  Recruit   SafeHer 
Interventions: Eligible patients with HER2-positive EBC will be allocated to one of the two following cohorts at the investigator’s discretion: • Cohort A (approximately 1800 patients): trastuzumab SC 600 mg via assisted administration into the thigh over a period of approximately 5 minutes using handheld syringes with hypodermic needles • Cohort B (approximately 700 patients): trastuzumab SC 600 mg, first assisted, then self-administered into the thigh over a period of approximately 5 minutes using the SID. For enrollment into Cohort B, patients need to be willing to self-administer the study drug from the SID based on personal instructions/training provided by an HCP during the first assisted administration in addition to a quick reference guide and an instructional animation describing the injection device handling and use, including how to respond if the SID loses sufficient contact with the body. 
INA-NK1QGRZ  Complete   A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A 
Interventions: This will be an open-label, randomized study and therefore treatment allocation will not be concealed. Eligible patients will be randomly allocated to Treatment Arm A (rituximab SC → rituximab IV) or Arm B (rituximab IV → rituximab SC) with a 1:1 ratio before dosing on Day 1 of Cycle 1. Randomization will occur using a centralized IxRS. Patients will be stratified according to age ( 
INA-A7OB6TW  Initial   Applying Wolbachia to Eliminate Dengue (AWED) Trial 
Interventions: Intervention arm: Deployment of Wolbachia-infected Aedes aegypty mosquitoes, in addition to standard practice dengue control activities Comparison arm: No intervention, Standard practice dengue control activities 
INA-GC3B3QY  Complete   NA 
Interventions: Tahap pertama: dilakukan pengambilan data ibu HIV dan bayinya. Tahap kedua: dilakukan pemeriksaan anti HIV sebelum dan saat persalinan dan bila anti HIV positiff, dilanjutkan pemeriksaan jumlah CD4 ibu. Pada saat bayi yang baru lahir dari ibu dengan HIV positif berusia 48 jam diperiksa PCR-DNA untuk menentukan satus infeksi bayi dan status terjadinya transmisi intra uterin. Juga dicatat apakah ibu sudah mendapat terapi ARV sebelum dan saat hamil. Semua bayi yang lahir dengan status HIV ibu positif tidak diberikan ASI. Bayi kemudian mendapatkan profilaksis ARV berupa zidovudin (dan nevirapin bila ibu belum mendapat ARV selama hamil) sesuai rekomendasi WHO selama 6 minggu. Setelah 6 minggu pemberian profilaksis ARV, bayi diperiksa PCR RNA. Semuabayi dengan hasil PCR-DNA dan atau PCR-RNA positif, langsung diberikan terapi ARV. Konfirmasi ulang dilakukan pemeriksaan PCR RNA pada usia bayi 12 minggu untuk menentukan status akhir infeksi pada bayi. 
INA-4E24W1E  Complete   NA 
Interventions: Pasien dibagi dalam 2 kelompok A dan B (setelah randomisasi) masing-masing mendapatkan obat sesuai pengelompokaan subyek selama 10 hari. Vitamin E menggunakan Santa E chewable caplet suatu DL-alpha-tocopheol dengan dosis 40 UI/hari (setara dengan Santa E 40mg) satu kali sehari yang dibuat dalam bentuk puyer. Placebo menggunakan sakarin dengan dosis dan dibuat salam bentuk puyer yang serupa dengan Santa E. 
INA-F7X6NA4  Initial   NA 
Interventions: Injeksi stem cells 
INA-SSS4TD0  Complete   Mesenchymal Stem cells ,spinal cord injury 
Interventions: Penyuntikan steam cells 
INA-OO80ADB  Initial   Global Safety T-DM1 Trial 
Interventions: - Test product: Trastuzumab emtansine (T-DM1) - Target population: This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. - Study design: Patients will be divided into two cohorts: Cohort 1 (approximately 2000 patients) and Cohort 2 (approximately 220 patients only of Asian race). Patients in each cohort will be administered trastuzumab emtansine intravenously every 3 weeks at a dose of 3.6 mg/kg until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2). 
INA-BXNGOQD  Initial   Global Safety T-DM1 Trial 
Interventions: - Test product: Trastuzumab emtansine (T-DM1) - Target population: This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. - Study design: Patients will be divided into two cohorts: Cohort 1 (2000 patients) and Cohort 2 (220 patients only of Asian race). Patients in each cohort will receive trastuzumab emtansine until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2) 
INA-KPA0DYA  Complete   NENOIN Study 
Interventions: NA NENOIN STUDY is designed to be a Phase IV/observational study and non-interventional. This observational study will not interfere with treatment prescription by Investigators. Accordingly, the Investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of the subject in the study. Subsequently, if the prescribed treatment is to be in line with the study protocol inclusion criteria, the Investigator will consider the possibility of including the subject in the study if subject signs informed consent form. 
INA-7GNRTO6  Initial   INA102 – TUBERCULOSIS RESEARCH OF INA-RESPOND ON DRUG RESISTANCE (TRIPOD) 
Interventions: N/A 
INA-9WS4RE6  Recruit   INA101: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE) 
Interventions: N/A 
INA-RX5D5QD  Recruit   Uji Klinis Probiotik Lactobacillus plantarum pada Pasien Dermatitis Atopik Anak di RSUD Dr. Soetomo Surabaya 
Interventions: • Metode Intervensi / Eksperimental Metode uji klinis terkontrol acak, tersamar ganda, tanpa pemilihan pasangan serasi, desain paralel • Bahan Uji ➢ Bahan uji pada kelompok perlakuan yaitu Lactobacillus plantarum 1,120 gram (10 pangkat 10 Colony Factor Unit) ➢ Bahan uji pada kelompok kontrol yaitu plasebo berupa campuran susu skim dan avicel (selulose) • Kondisi Kesehatan Subyek Pasien dermatitis atopik anak usia 0-14 tahun dengan keadaan umum baik dan memenuhi kriteria inklusi 
INA-R5PG64K  Recruit   Uji Klinis Gel Produk Metabolisme Sel Punca Membran Amnion pada Penyembuhan Luka Kronis Telapak Kaki Pasien Kusta 
Interventions: Metode Intervensi/Eksperimental : Uji klinis terkontrol, pemilihan pasangan serasi,desain paralel Bahan Uji: - Pada kelompok perlakuan : produk metabolit Amniotic Membrane Stem Cell (AMSC) yang diperoleh dari Laboratorium Stem Cell, Institute Tropical Disease, Universitas Airlangga, yang dibuat gel terlebih dahulu supaya dapat diaplikasikan pada luka. - Pada kelompok kontrol : framycetin gauze dressing Kondisi Kesehatan Subyek Penelitian : Pasien Morbus Hansen dengan keadaan umum baik, dengan ulkus plantar kronis sederhana yang memenuhi kriteria inklusi dan eksklusi 
INA-DCD9X4Y  Recruit   Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE) 
Interventions: Observational: Cohort Prospective 
INA-Z758Y83  Recruit   Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia 
Interventions: Experimental: Tetronine Oral T3 (Tetronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours Intervention: Drug: Tetronine Placebo Comparator: Placebo Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anesthesia for 60 hours Intervention: Drug: Placebo 
INA-D1C540Y  Initial   manfaat xilostazol untuk perbaikan luka pada gangren diabetik 
Interventions: minum oabt dua kali sehari................. .................. .............. 
INA-YHDPEN2  Initial   Pengaruh Rokok terhadap kanker paru 
Interventions: Bahan : Rokok Placebo : Permen 
INA-BK9O54S  Initial   High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study (ReDEFINe) 
Interventions: Experimental: Rifampicin 900 mg per oral Twenty patients will receive 2 tablets of 450 mg Rifampicin and 1 tablet of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) Placebo Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet. Patients receiving 1350 mg rifampicin will not receive any placebo tablet. With this arrangement, every subject will receive 3 tablets of study drugs. Drug: Rifampicin Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin. Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section. Other Name: Rifampisin - Kimia Farma Drug: Other TB drugs Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) Drug: Adjuvant dexamethasone Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)