| No Registry |
Status |
Registry |
| |
Recruit
|
Minhai-PCV13 Study
| Interventions: |
Study vaccine: PCV13 (Pneuminvac)
Provided by: Minhai Biotechnology Co., Ltd
Dosage: 0.5 mL single-dose prefilled syringes
Appearance: white suspension
Dosage form: Injection
Route of administration: intramuscular injection into the anterolateral aspect of the thigh |
|
| |
Complete
|
Bioequivalence Study of Fluoxetine 20 mg Tablets Manufactured by PT LAPI Laboratories, Cikande - Serang in Comparison with Prozac® 20 mg Capsules Manufactured by Patheon France S.A.S for Eli Lilly and Company, Indianapolis, USA, Imported by PT Pyridam Farma Tbk, Cianjur, Indonesia.
| Interventions: |
Fluoxetine 20 mg Tablets |
|
| |
Complete
|
Bioequivalence Study of 15 mg Meloxicam Tablet Manufactured by PT Novapharin in comparison with 15 mg Movalis® Tablet Manufactured by Boehringer Ingelheim RCV GmbH & CO KG, Wien Austria.
| Interventions: |
Meloxicam 15 mg Tablet Manufactured by PT Novapharin |
|
| |
Complete
|
Uji Perbandingan Kualitas Obat Selvim® 10 (Simvastatin 10 mg) dengan Obat Standar Zocor® 10 ( Simvastatin 10 mg)
|
| |
Complete
|
BIOEQUIVALENCE STUDY OF AZITHROMYCIN 500 MG FILM COATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH ZITHROMAX® 500 MG FILM-COATED TABLETS MANUFACTURED BY PT PFIZER INDONESIA UNDER SUPERVISION FROM PFIZER INC., NEW YORK, NY., USA
| Interventions: |
Azithromycin 500 mg film-coated tablets manufactured by PT Kimia Farma Tbk. |
|
| |
Complete
|
The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery.
| Interventions: |
Scalp nerve block was performed with 0.5% ropivacaine |
|
| |
Complete
|
The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery
| Interventions: |
scalp nerve block was performed with 0.5% ropivacaine |
|
| INA-3L1XRW7 |
Complete
|
Bioequivalence study of Lamotrigine 100 mg tablet produced by PT Yarindo Farmatama in comparison with Lamictal® (Lamotrigine 100 mg) tablet manufactured by GlaxoSmith Kline Pharmaceuticals S.A., Poznan, Poland, imported by PT Glaxo Wellcome Indonesia.
| Interventions: |
Test Drug: Lamotrigine 100 mg tablet PT Yarindo Farmatama |
|
| INA-XO4B1RT |
Complete
|
Bioequivalence Study of Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories in Comparison with Mobic® (Meloxicam 15 mg) Tablet Produced by Boehringer Ingelheim Pty Limited, Australia
| Interventions: |
Meloxicam 15 mg Tablet Produced by PT Trifa Raya Laboratories |
|
| INA-YBCTODT |
Complete
|
Bioequivalence Study of Glimepiride 1 mg tablet, Glamarol® manufactured by PT Guardian Pharmatama in comparison with Glimepiride 1 mg tablet, Amaryl® manufactured by PT Aventis Pharma, Indonesia
| Interventions: |
Glimepiride 1 mg tablet, GLAMAROL® manufactured by PT Guardian Pharmatama |
|
| INA-445XLCA |
Complete
|
Bioequivalence Study of 10 mg Amlodipine Besilate Caplets Produced by PT. Harbat Farma in Comparison with Norvask® 10 mg Tablets Manufactured by PT. Pfizer Indonesia
| Interventions: |
Amlodipine Besilate caplets Produced by PT Harbat Farma |
|
| INA-79MT69O |
Complete
|
Bioequivalence study of amlodipine 10 mg tablet produced by PT Marin Liza Farmasi 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 test drug (amlodipine 10 mg tablet produced by PT Marin Liza Farmasi) or one of comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia) with approximately 200 mL of water at ambient temperature. |
|
| INA-99K01HH |
Complete
|
Bioequivalence study of febuxostat 80 mg film-coated caplet produced by PT Lapi Laboratories in comparison with the comparator drug (Feburic® 80 mg Film-Coated Tablet manufactured by Patheon France, France, imported by PT Meprofarm Pharmaceutical Industries, Indonesia)
| Interventions: |
febuxostat 80 mg film-coated caplet produced by PT Lapi Laboratories |
|
| INA-ST4A0XN |
Complete
|
Uji Bioekivalensi Acartesan® 120 FCT (Etorikoksib 120 mg) Produksi PT Sanbe Farma Dibandingkan Terhadap ArcoxiaTM 120 mg FCT (Etorikoksib 120 mg) Produksi Rovi Pharma Industrial Services S.A., Spanyol Didaftarkan dan Dikemas oleh PT Organon Pharma Indonesia Tbk, Indonesia Pada Subjek Sehat
| Interventions: |
Obat (Acartesan® 120/ArcoxiaTM 120 yang mengandung Etoricoxib 120 mg) diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul 06.00–07.00 WIB dengan 220 mL air pada suhu ruang. |
|
| |
Complete
|
Bioequivalence Study of Zycin® 500 mg Film-Coated Caplets Manufactured by PT Interbat in Comparison with Zithromax® 500 mg Film-Coated Tablets Manufactured by PT Pfizer Indonesia Under Supervision from Pfizer Inc., New York, NY., USA
| Interventions: |
Zycin® 500 mg Film-Coated Caplets |
|
| INA-DESON1D |
Recruit
|
NA
| Interventions: |
Fexuprazan tablet 40 mg |
|
| INA-PCG7QAR |
Complete
|
Bioequivalence study of meloxicam 15 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Mobic® 15 mg Tablet produced by PT Boehringer Ingelheim Indonesia, Indonesia)
| Interventions: |
Test drug: meloxicam hydrochloride 15 mg tablet produced by PT Dexa Medica |
|
| INA-Q9EC6OB |
Complete
|
An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS-CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old
| Interventions: |
INAVAC (Vaksin Merah Putih - UA-SARS-CoV-2 (Vero Cell Inactivated)) |
|
| INA-6D5D9F9 |
Complete
|
Immunobridging Study: Immunogenicity and Safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) Vaccine as Heterologue Booster in Adolescent Subjects in Indonesia
| Interventions: |
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) Vaccine |
|
| INA-KFDR0OX |
Complete
|
PoP BCG Trial
| Interventions: |
Vaksin BCG |
|
| INA-2ETBDZ8 |
Complete
|
A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines
| Interventions: |
SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO CoV.617.1) |
|
| INA-GR9GFQH |
Complete
|
Immunogenicity and Safety Study of Half Dose of Moderna COVID-19 Vaccine Booster Heterologous in Adult Subjects in Indonesia
| Interventions: |
Moderna COVID-19 vaccine booster |
|
| INA-5L15LDW |
Complete
|
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GX-19N, A COVID-19 Preventive DNA Vaccine in Healthy Individuals
| Interventions: |
GX-19N, A COVID-19 Preventive DNA Vaccine |
|
| INA-P0HETP2 |
Complete
|
Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Protective Efficacy, Safety and Immunogenicity of SARS-CoV02 Messenger Ribonucleic Acid (mRNA) Vaccine in Population Aged 18 Years and Older
| Interventions: |
SARS-CoV02 Messenger Ribonucleic Acid (mRNA) Vaccine |
|
| INA-FL3FKKS |
Complete
|
Bioequivalence Study of Salbutamol Caplets 4 mg (Bronchosal Caplets) Manufactured by PT IFARS Pharmaceutical Laboratories Compared to Albuterol Tablet 4 mg Manufactured by Appco Pharma LLC for Rising Pharmaceuticals, Inc.
| Interventions: |
Salbutamol Caplets 4 mg (Bronchosal Caplets) manufactured by PT IFARS Pharmaceutical Laboratories |
|
| INA-8Z5GBGN |
Complete
|
Bioequivalence Study of Paracetamol 250 mg Suppository, Pamol® 250 manufactured by PT Interbat in comparison with Paracetamol 250 mg Suppository, Panadol Children® manufactured by GlaxoSmithKline Consumer Healthcare, Australia
| Interventions: |
Paracetamol 250 mg Suppository, Pamol® 250 manufactured by PT Interbat |
|
| INA-KYD007Q |
Complete
|
bioequivalence study of Clopidogrel 75 mg film coated tablet manufactured by PT Bernofarm in comparison with Clopidogrel 75 mg film coated tablet, Plavix® manufactured by PT Aventis Pharma, Jakarta, Indonesia; Under licensed by Sanofi Clir SNC, France
| Interventions: |
Clopidogrel 75 mg film coated tablet manufactured by PT Bernofarm |
|
| INA-Z66B4Z9 |
Complete
|
Bioequivalence study of Rivaroxaban 20 mg film coated tablet manufactured by PT.Mersifarma Tirmaku Mercusana in comparison with Rivaroxaban 20 mg film coated tablet, Xarelto® manufactured by Bayer AG, Leverkusen-Germany; imported by PT.Bayer Indonesia, Depok-Indonesia.
| Interventions: |
Rivaroxaban 20 mg tablet salut selaput, manufactured by PT Mersifarma Tirmaku Mercusana |
|
| INA-ZTNXS1D |
Initial
|
Uji validitas metode dan performa klinis dari PathoScan HBV Viral Load dalam mendeteksi dan mengukur konsentrasi DNA virus Hepatitis B pada spesimen klinis
|
| INA-GFHB5KE |
Complete
|
Bioequivalence study of Levamlodipine 5 mg tablet produced by PT Pratapa Nirmala in comparisonwith Conjupri (Xuanning) (Levamlodipine 2.5 mg) tablet manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.
| Interventions: |
Test Drug: Levamlodipine 5 mg tablet produced by PT Pratapa Nirmala |
|
| INA-ANXT200 |
Complete
|
BIOEQUIVALENCE STUDY OF GLIDIA MR (GLICLAZIDE 60 MG) MODIFIED RELEASE CAPLET PRODUCED BY PT KONIMEX IN COMPARISON WITH DIAMICRON® MR (GLICLAZIDE 60 MG) MODIFIED RELEASE TABLET MANUFACTURED BY LES LABORATOIRES SERVIER INDUSTRIE, FRANCE, REGISTERED BY PT DARYA VARIA LABORATORIA TBK., INDONESIA, IMPORTED AND MARKETED BY PT SERVIER INDONESIA
| Interventions: |
GLIDIA MR (GLICLAZIDE 60 MG) MODIFIED RELEASE CAPLET PRODUCED BY PT KONIMEX |
|
| INA-KLM3A7D |
Complete
|
Bioequivalence Study of Rosuvastatin 20 mg Film Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Rosuvastatin 20 mg Film Coated Tablet, Crestor® manufactured by IPR Pharmaceuticals Inc. Puerto Rico for AstraZeneca UK Limited, United Kingdom; packed and released by AstraZeneca Pharmaceutical Co.Ltd, China; imported by PT AstraZeneca Indonesia
| Interventions: |
Rosuvastatin 20 mg Film Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri |
|
| INA-7FLZR8S |
Complete
|
Bioequivalence study of Tracetate (Megestrol Acetate 160 mg) tablet produced by PT Pratapa Nirmala in comparison with Megace® 160 mg (Megestrol Acetate 160 mg) tablet manufactured by Haupt Pharma Amareg GmbH, Regensburg, Germany, under marketing authorization holder of Bausch Health Ireland Limited
| Interventions: |
Test Drug: Tracetate (Megestrol Acetate 160 mg) tablet PT Pratapa Nirmala |
|
| INA-LTNNFLH |
Recruit
|
The Implementation of WHO iSupport Training Module Bahasa Version: Protocol for Experimental Study
| Interventions: |
The intervention group will receive training through sessions based on the WHO iSupport guide in the Indonesian version. The meetings will be divided into 7 sessions, a mix of online and offline meetings. |
|
| INA-7MK049A |
Complete
|
Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT Mulia Farma Suci in
Comparison with Mobic® 15 mg Tablet Manufactured by PT Boehringer Ingelheim Indonesia,
Imported by Boehringer Ingelheim (Philippines), Inc., Makati City.
| Interventions: |
Meloxicam 15 mg tablet |
|
| INA-KQ0365L |
Complete
|
BIOEQUIVALENCE STUDY OF FUROSEMIDE 40 MG TABLET PRODUCED BY PT FIRST MEDIPHARMA IN COMPARISON WITH LASIX® (40 MG FUROSEMIDE) TABLET PRODUCED BY PT AVENTIS PHARMA, INDONESIA
| Interventions: |
The participating subjects were ordered to stay overnight in the laboratory staying room before the day of blood sampling and abstain from taking any medication for at least one week before and during period of study. In the next morning (first day of each period) subjects were given orally one of test drug (40 mg Furosemide, produced by PT. First Medipharma) or one of comparator drug (40 mg Lasix, produced by PT. Aventis Pharma, Indonesia) |
|
| INA-T40TO0W |
Complete
|
Bioequivalence study of fluoxetine 20 mg caplet produced by PT Dexa Medica in comparison with the comparator drug (Prozac® 20 mg Capsule produced by Patheon France, S.A.S, France, for Eli Lilly and Company, USA, registered by PT Pyridam Farma Tbk, Indonesia) when administered under fasting condition in healthy subjects.
| Interventions: |
Test drug: fluoxetine 20 mg caplet produced by PT Dexa
Reference drug: Prozac® 20 mg Capsule produced by Patheon France, S.A.S, France, for Eli Lilly and Company, USA, registered by PT Pyridam Farma Tbk, Indonesia |
|
| INA-HN3ZYKS |
Complete
|
Bioequivalence Study of Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri in comparison with Ondansetron 8 mg Tablet, Zofran® manufactured by Aspen Bad Oldesloe GmBH, Germany; registration holder by Novartis Taiwan Co., Ltd.
| Interventions: |
Ondansetron 8 mg Film-Coated Tablet manufactured by PT Promedrahardjo Farmasi Industri |
|
| INA-M6482OE |
Complete
|
Bioequivalence study of amlodipine 10 mg tablet produced by PT Novapharin 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 test drug (amlodipine 10 mg tablet produced by PT Novapharin) or one of comparator drug (Norvask® 10 mg Tablet, PT Pfizer Indonesia) with approximately 200 mL of water at ambient temperature. |
|
| INA-KR5CN0X |
Initial
|
Education Model for Medication Adherence in Essential Hypertension Patients
| Interventions: |
Before the intervention, subjects were invited to the posbindu or health center to be given an explanation of the objectives, benefits, risks, and procedures in this study. The intervention given to the subjects in the treatment group was in the form of education to improve knowledge, self-efficacy, and compliance in taking antihypertensive medication in patients with essential hypertension. Education was arranged in the form of an independent learning module that could be accessed by the subjects via their mobile phones. The independent learning module was arranged digitally based on Android. Subjects were guided to download the learning module via their respective mobile phones. Subjects accessed the learning module (sessions 1-5) anywhere and anytime according to the subjects' convenience, but in one day the subjects accessed and studied 1 (one) session of material for ±5 (five) minutes. The education module was accessed and studied independently by the subjects in the treatment group for 6 (six) sessions with the following details: Session 1 was given on day 1, subjects studied material on the definition, symptoms and signs of hypertension sufferers; Session 2 was given on day 2, subjects studied material on the vulnerability and severity of hypertension sufferers who did not take antihypertensive medication;
Session 3 was given on day 3, subjects studied material on the benefits and obstacles of hypertension sufferers who took antihypertensive medication;
Session 4 was given on day 4, subjects studied material on motivation to increase their self-confidence in taking antihypertensive medication;
Session 5 was given on day 5, subjects studied material on the time and how to take antihypertensive medication, schedule for taking antihypertensive medication, where to take antihypertensive medication, who and where to look for information on hypertension treatment.
Session 6 was conducted after subjects finished accessing the material on days 1-5, in session 6 subjects were invited to attend a meeting at the posbindu or health center. The meeting aimed to monitor the completeness of material access and the subject's knowledge of the educational material (days 1-5). Monitoring access to the material was done by asking the subject directly about the sessions they attended, while monitoring the achievements was done by having the subject fill out an electronic questionnaire that was integrated with the module on their mobile phone. The educational material that was accessed in 5 (five) sessions was repeated to be accessed again by the subject 4 times. |
|
| INA-BO957GY |
Complete
|
Peran prokalsitoninsebahgai parameter terapi antibiotik terhadap durasi terapi antibiotik dal luaran klinis pada pasien sakit kritis dengan kecurigaan infeksi bakteri di Intensive Care Unit: Studi Aplikasi Procalcitonin Algorithm for Antibiotic Therapy Decision (ProATIC)
|
| INA-9BK3XDQ |
Recruit
|
“A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study of Serplulimab in
Combination with Bevacizumab and Chemotherapy (XELOX) versus Placebo in Combination
with Bevacizumab and Chemotherapy (XELOX) in First-Line Treatment of Patients with
Metastatic Colorectal Cancer (mCRC)”
| Interventions: |
Serplulimab + Bevacizumab + Chemotherapy (XELOX) |
|
| INA-WF88388 |
Complete
|
Bioequivalence Study of 40 mg Esomeprazole Gastro-Resistant Coated Tablets Manufactured by PT. Dankos Farma in Comparison with 40 mg Nexium® MUPS Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden.
| Interventions: |
Esomeprazole 40 mg gastro-resistant coated tablet |
|
| INA-20HHW1T |
Complete
|
Bioequivalence Pilot Study of Candesartan Cilexetil Tablet 16 mg Produced by PT Kimia Farma Tbk Compared to Blopress® Tablet 16 mg Produced by PT. Takeda Indonesia, Bekasi, Indonesia Under License of Takeda Pharmaceutical Company Limited, Osaka, Japan.
| Interventions: |
Candesartan Cilexetil Tablet 16 mg by PT. Kimia Farma Tbk |
|
| INA-FB1Q7SA |
Complete
|
Bioequivalence Study of Bilastine 20 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Bilaxten® 20 mg Tablet Manufactured by Faes Farma, S.A.
| Interventions: |
Bioequivalence Study of Bilastine 20 mg Tablet Manufactured by PT Kimia Farma Tbk |
|
| INA-2RZHCHX |
Complete
|
BIOEQUIVALENCE STUDY OF TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ FILM-COATED TABLETS 300
MG/300 MG/600 MG PRODUCED BY PT. KIMIA FARMA Tbk COMPARED TO SYMFI® PRODUCED BY MYLAN LABORATORIES LIMITED INDIA, REGISTERED BY MYLAN SPECIALTY L.P. USA
| Interventions: |
Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-Coated Tablets 300 mg/300 mg/600 mg produced by PT. Kimia Farma Tbk. |
|
| INA-0DW691N |
Complete
|
Bioequivalence Pilot Study of Loprezol 30 mg Extended-Release Capsule Produced by PT.Kimia Farma Tbk Compared to Prosogan FD 30 mg Enteric-Coated Tablet Produced by Kokando Co., Ltd., Toyama, Japan for Takeda Pharmaceutical Company Limited, Osaka, Japan
| Interventions: |
Loprezol (Lansoprazole) 30 mg Capsule by PT. Kimia Farma Tbk |
|
| INA-PYFN0ZY |
Complete
|
Bioequivalence Study of Diltiazem Hydrochloride 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Herbesser® 30 mg Tablet produced by PT. Mitsubishi Tanabe Pharma Indonesia.
| Interventions: |
Diltiazem Hydrochloride 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared |
|
| INA-GZCKNZZ |
Complete
|
Bioequivalence Study of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk Compared to Symfi® Produced by Mylan Laboratories Limited India, Registered by Mylan Specialty L.P. USA
| Interventions: |
Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film-coated Tablets 300mg/300 mg/600 mg Produced by PT Kimia Farma Tbk |
|
| INA-XYCP4C4 |
Complete
|
Bioequivalence Pilot 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 by PT. Kimia Farma Tbk |
|
| INA-N24PRW2 |
Complete
|
Bioequivalence Study of Simvastatin 20 mg Film Coated Tablet Manufactured by PT Kimia Farma Tbk Compared to Zocor® 20 mg Tablet Manufactured by Merck Sharp & Dohme, ltd. United Kingdom
| Interventions: |
Simvastatin 20 mg Film Coated Tablet Manufactured by PT Kimia Farma Tbk |
|
| INA-SG6AOHB |
Complete
|
Bioequivalence Study of FDC-4 Film-Coated Caplets Manufactured by PT Kimia Farma Tbk in Comparison with Rifinah® 300/150 mg Coated Tablets Manufactured by Sanofi S.r.l., Anagni, Italy, and Pyrafat® 500 mg Film Tablets Manufactured by SW Pharma GmbH, Germany, and Myambutol® 400 mg Film Tablets Manufactured by Labatec-Pharma SA, 1217 Meyrin, Switzerland.
| Interventions: |
FDC-4 FILM-COATED CAPLETS MANUFACTURED BY PT KIMIA FARMA TBK |
|
| INA-YM1T4HH |
Complete
|
Bioequivalence Pilot Study of Zidovudine 100 mg Capsule Manufactured by PT Kimia Farma Tbk Compared to Retrovir® 100 mg Capsule (Innovator) Manufactured by ViiV Healthcare
| Interventions: |
Zidovudine 100 mg Capsule Manufactured by PT Kimia Farma Tbk |
|
| INA-5QYTBZ5 |
Complete
|
Bioequivalence Study of Efavirenz 200 mg Film-coated Tablet Manufactured by PT Kimia Farma Tbk Compared to Stocrin® 200 mg Film-Coated Tablet (Innovator) Manufactured by Merck Sharp Dohme, Tokyo, Japan.
| Interventions: |
Efavirenz 200 mg Film-coated Tablet Manufactured by PT Kimia Farma Tbk |
|
| INA-HAKBZY2 |
Complete
|
Bioequivalence Study of Glimepiride 4 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Amaryl® 4 mg Tablet (Innovator) Manufactured by PT. Aventis Pharma Indonesia.
| Interventions: |
Glimepiride 4 mg Tablet Manufactured by PT Kimia Farma Tbk |
|
| INA-SP84MAG |
Complete
|
Bioequivalence Study of Tenofovir Disoproxil Fumarate 300 mg Film-Coated Tablet Manufactured by PT Kimia Farma Tbk Compared to Viread® 300 mg Tablet (Innovator) Manufactured by Gilead Sciences Ireland.
| Interventions: |
Tenofovir Disoproxil Fumarate 300 mg Film-Coated Tablet Manufactured by PT Kimia Farma Tbk |
|
| INA-ETM8ROG |
Complete
|
Bioequivalence Study of Tenofovir Disoproxil Fumarate 300 mg Film-Coated Tablet Manufactured by PT Kimia Farma Tbk Compared to Viread® 300 mg Tablet (Innovator) Manufactured by Gilead Sciences Ireland.
| Interventions: |
Tenofovir Disoproxil Fumarate 300 mg Film-Coated Tablet Manufactured by PT Kimia Farma Tbk |
|
| NA-D16E5G3 |
Complete
|
Bioequivalence Study of Pioglitazone 30 mg Tablet Manufactured by PT Kimia Farma Tbk Compared to Actos® 30 mg Tablet (Innovator) Manufactured by PT. Takeda Indonesia License from Takeda Pharmaceuticals COmpany Limited. Osaka, Japan.
| Interventions: |
Pioglitazone 30 mg Tablet manufactued by PT Kimia Farma tbk, Indonesia |
|
| INA-8F34TC3 |
Complete
|
Bioequivalence Study of Ketoconazole 200 mg Tablets (Omegzole 200 mg) Manufactured by PT Mutiara Mukti Farma in Comparison with Ketoconazole 200 mg Tablets Manufactured by Taro Pharmaceutical Industries Ltd., Israel, distributed by Taro Pharmaceuticals U.S.A., Inc., United States
| Interventions: |
Ketoconazole 200 mg Tablets |
|
| INA-KT58Q6Z |
Complete
|
Bioequivalence Study of Piroxicam 20 mg Capsules (Omeretik 20 mg) Manufactured by PT Mutiara Mukti Farma in Comparison with Feldene® 20 mg Capsules Manufactured by Fareva Amboise, France, Marketing Authorization Holder by Pfizer Italia S.r.l.
| Interventions: |
Piroxicam 20 mg Capsules |
|
| INA-ZFG64K8 |
Complete
|
BIOEQUIVALENCE STUDY OF RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH RIFINAH ® 150 MG/100 MG TABLETS MANUFACTURED BY SANOFI S.R.L,ANAGNI, ITALY
| Interventions: |
RIFAMPICIN 75 MG/ISONIAZID 50 MG (FDC-2) DISPERSIBLE TABLETS |
|
| INA-HS37O6Y |
Complete
|
Bioequivalence Study of Pehadoxin Forte Tablet (Isoniazid 400 mg + Vitamin B6 10 mg) Manufactured by PT Phapros Tbk Compared to Isozid® 100 mg Tablet Manufactured by Riemser Pharma GmbH.
| Interventions: |
Pehadoxin Forte Tablet (Isoniazid 400 mg + Vitamin B6 10 mg) Manufactured by PT Phapros Tbk |
|
| INA-KYHRHQ2 |
Complete
|
Bioequivalence study of Ruvastin® 40 (Rosuvastatin 40 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Crestor® 40 (Rosuvastatin 40 mg) film coated tablet 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: |
Test drug: Ruvastin® 40 (Rosuvastatin 40 mg) film coated tablet |
|
| INA-02BKQ4A |
Complete
|
Bioequivalence Study Of Valogrel® 75 (Clopidogrel 75 Mg) Film Coated Tablet Produced by PT IFARS Pharmaceutical Laboratories in Comparison with Plavix® 75 (Clopidogrel 75 Mg) Film Coated Tablet Manufactured by PT Aventis Pharma, Jakarta, Indonesia, Under License of Sanofi Clir Snc, France
|
| INA-K090O0O |
Complete
|
Bioequivalence study of Lansoprazole 30 mg delayed-release capsule manufactured by PT Nulab Pharmaceutical Indonesia in comparison with Lansoprazole 30 mg enteric coated tablet, Prosogan® FD manufactured and release by Kokando Co. Ltd., Toyama, Japan; for Takeda Pharmaceuticals Company Limited, Osaka, Japan; imported and packed by Takeda Indonesia
| Interventions: |
Lansoprazole 30 mg delayed-release capsule manufactured by PT Nulab Pharmaceutical Indonesia |
|
| INA-2DTW5N4 |
Complete
|
Bioequivalence study of Aripiprazole 10 mg orally disintegrating tablet, manufactured by PT Mersifarma Tirmaku Mercusana in comparison with Aripiprazole 10 mg orally disintegrating tablet, Abilify Discmelt® manufactured by Korean Otsuka Phamaceutical Co., Ltd; registered by PT Otsuka Indonesia
| Interventions: |
Aripiprazole 10 mg orally disintegrating tablet, manufactured by PT Mersifarma Tirmaku Mercusana |
|
| INA-WASFLBR |
Complete
|
Bioequivalence Study of Primaquine Phosphate 15 mg Tablet Manufactured by PT Phapros Tbk Compared to Primaquine Phosphate 15 mg Tablet Manufactured by Sanofi-Aventis U.S LLC
| Interventions: |
Primaquine Phosphate 15 mg Tablet Manufactured by PT Phapros Tbk |
|
| INA-4GB0N40 |
Complete
|
bioequivalence study of Paracetamol 125 mg Suppository, Pamol® 125 manufactured by PT Interbat in comparison with Paracetamol 125 mg Suppository, Ben-u-ron® 125 manufactured by Bene-Arzneimittel GmbH, Deutschland
| Interventions: |
Paracetamol 125 mg Suppository, Pamol® 125 manufactured by PT Interbat |
|
| INA-S0H63SX |
Initial
|
BIOEQUIVALENCE STUDY OF VALISANBE® 5 TABLET (5 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 5 mg TABLET (5 mg DIAZEPAM) MANUFACTURED BY WAYLIS THERAPEUTICS LLC, USA IN HEALTHY SUBJECTS
|
| INA-597F7QT |
Complete
|
Bioequivalence Study of 10 mg Amlodipine Besylate Caplets Manufactured by PT Pabrik
Pharmasi Zenith in Comparison with 10 mg Norvask® Tablets Manufactured by PT Pfizer
Indonesia
| Interventions: |
10 mg Amlodipine |
|
| INA-7ROGO7H |
Complete
|
Bioequivalence Study of Omeprazole 20 mg Capsules (Zeprazol) Manufactured by PT Pabrik
Pharmasi Zenith in Comparison with Losec® 20 mg Capsules Manufactured by AstraZeneca,
Sweden, Authorized and Marketed by Cheplapharm Arzneimittel GmbH, Germany.
| Interventions: |
Zeprazol 20 mg (omeprazole 20 mg) |
|
| INA-G974THG |
Complete
|
BIOEQUIVALENCE STUDY OF 10 MG AMLODIPINE BESILATE TABLET MANUFACTURED BY PT MEDIKON PRIMA
LABORATORIES IN COMPARISON WITH 10 MG NORVASK® TABLET MANUFACTURED BY PT PFIZER INDONESIA
| Interventions: |
AMLODIPINE BESILATE 10 MG TABLET |
|
| INA-83WLOOH |
Complete
|
Bioequivalence Study of Azithromycin Dihydrate 500 mg Film-Coated Caplets Manufactured by PT Medikon
Prima Laboratories in Comparison with Zithromax® 500 mg Film-Coated Tablets Manufactured by PT Pfizer
Indonesia Under Supervision from Pfizer Inc., New York, NY., USA.
| Interventions: |
Azithromycin Dihydrate 500 mg film-coated caplets |
|
| INA-4YSRMQS |
Complete
|
Bioequivalence Study of Sitagliptin Phosphate 100 mg Film-Coated Tablets Manufactured by PT BrightGene Biomedical Indonesia in Comparison with Januvia™ 100 mg Film-Coated Tablets Manufactured by Organon Pharma (UK) Limited, Cramlington – England, Registered and Packed by PT Organon Pharma Indonesia Tbk, Pasuruan, Jawa Timur – Indonesia, Distributed by PT Merck Sharp & Dohme Indonesia, Jakarta - Indonesia
|
| INA-487H0W1 |
Complete
|
Bioequivalence Study of Fenofibrate 160 mg Film-Coated Caplet Manufactured by PT Interbat in Comparison with Lipanthyl Supra® 160 mg Film-Coated Tablet Manufactured by Recipharm Fontaine, France, Imported by PT Abbott Indonesia
| Interventions: |
Fenofibrate 160 mg film-coated caplet |
|
| INA-TNWH59R |
Complete
|
Bioequivalence Study of 10 mg Isosorbide Dinitrate Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Cedocard® 10 mg Tablets Manufactured and Marketed by PT. Darya-Varia Laboratoria Tbk, Indonesia, Under License From Takeda Netherland bv, The Netherlands
| Interventions: |
Isosorbide DinitrateTablet 10 mg manufactured by PT Novell Pharmaceutical Laboratories |
|
| INA-P8T343X |
Complete
|
Bioequivalence Study of 75 mg Clopidogrel Film Coated Tablets Produced by PT. Novell
Pharmaceutical Laboratories in Comparison with Plavix® 75 mg Film Coated Tablets Manufactured by Sanofi Winthrop Industrie, France
| Interventions: |
Clopidogrel 75 mg Tablet manufactured by PT Novell Pharmaceutical Laboratories |
|
| INA-KHOLSX0 |
Complete
|
Bioequivalence Study of 150 mg Fluconazole Capsules Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Diflucan® 150 mg Capsules Manufactured by PT. Pfizer Indonesia
| Interventions: |
Fluconazole 150 mg Capsules manufactured by PT Novell Pharmaceutical Laboratories |
|
| INA-9ECWDS6 |
Complete
|
BIOEQUIVALENCE STUDY OF VALISANBE® 2 TABLET (2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG,
SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA IN HEALTHY SUBJECTS
|
| INA-YD5K8RO |
Complete
|
Bioequivalence Study of Etoricoxib 120 mg Film-Coated Tablets Manufactured by PT
Combiphar in Comparison with Arcoxia® 120 mg Film-Coated Tablets Manufactured by
Rovi Pharma Industrial Services S.A., Spain, Imported by PT Organon Pharma Indonesia
Tbk, Pasuruan
| Interventions: |
Etoricoxib 120 mg film-coated tablet |
|
| INA-XGWK68E |
Complete
|
BIOEQUIVALENCE STUDY OF RIFAMPICIN 600 MG FILMCOATED TABLETS MANUFACTURED BY PT KIMIA FARMA TBK,
JAKARTA IN COMPARISON WITH RIFADIN® (2 x 300 MG) CAPSULES MANUFACTURED BY SANOFI S.R.L, ITALY
| Interventions: |
RIFAMPICIN 600 MG FILM COATED TABLETS |
|
| INA-RKWBLPZ |
Complete
|
bioequivalence study of Rivaroxaban 20 mg film coated tablet, Rivatero manufactured by PT Amarox Pharma Global in comparison with Rivaroxaban 20 mg film coated tablet, Xarelto manufactured by Bayer AG, Leverkusen
| Interventions: |
Rivaroxaban 20 mg film coated tablet, Rivatero manufactured by PT Amarox Pharma Global |
|
| INA-WFRKK44 |
Complete
|
UJI BIOEKIVALENSI TABLET OSTELOX® 15 (MELOKSIKAM 15 mg) PRODUKSI PT SANBE FARMA DIBANDINGKAN TERHADAP MOVALIS® 15 mg (MELOKSIKAM 15 mg) PRODUKSI BOEHRINGER INGELHEIM ELLAS AE, YUNANI PADA SUBJEK SEHAT
| Interventions: |
Meloxicam (test drug) diberikan dalam keadaan puasa dan dalam posisi duduk pada pukul
06.00–07.00 WIB dengan 220 mL air pada suhu ruang. |
|
| INA-GSLD63S |
Complete
|
Bioequivalence study of Tracetate 200 mL (Megestrol Acetate 40 mg/mL) oral suspension produced by PT Pratapa Nirmala in comparison with Megestrol Acetate 40 mg/mL oral suspension, USP, manufactured by Strides Pharma Inc., distributed by Strides Pharma Inc., East Brunswick, NJ.
|
| INA-B6YPM6R |
Complete
|
Bequivalence study of Meloxicam 15 mg tablet manufactured by PT Otto Pharmaceutical Industries in comparison with Meloxicam 15 mg tablet, Mobic® manufactured by Boehringer Ingelheim Pty Limited, Sydney, Australia
| Interventions: |
Meloxicam 15 mg tablet manufactured by PT Otto Pharmaceutical Industries |
|
| INA-H9FTPB4 |
Complete
|
Bioequivalence Study of Pioglitazone 30 mg Tablets Manufactured by PT Dankos Farma for PT Hexpharm Jaya in Comparison with Actos® 30 mg Tablets Manufactured by PT Takeda Indonesia, Bekasi, Indonesia, under license of Takeda Pharmaceutical Company Limited, Japan
| Interventions: |
Pioglitazone 30 mg tablets |
|
| INA-Y4XP7NW |
Complete
|
Bioequivalence Study of Piroxicam 20 mg (Faxiden® Caplets) Manufactured by PT. IFARS Pharmaceutical Laboratories in Comparison with Piroxicam 20 mg (Feldene® Capsules) Manufactured by PT Pfizer Italia S.R.I
| Interventions: |
Piroxicam 20 mg (Faxiden® Caplets) Manufactured by PT. IFARS Pharmaceutical Laboratories |
|
| INA-L12M0W3 |
Complete
|
BIOEQUIVALENCE STUDY OF ANALSIK® FCC (500 mg METAMIZOLE SODIUM AND 2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG, SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA AND NOVALGIN® CAPLET (500 mg METAMIZOLE SODIUM) MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA FOR PT KALVENTIS SINERGI FARMA, INDONESIA IN HEALTHY SUBJECTS
| Interventions: |
BIOEQUIVALENCE STUDY OF ANALSIK® FCC (500 mg METAMIZOLE SODIUM AND 2 mg DIAZEPAM) MANUFACTURED BY PT SANBE FARMA IN COMPARISON WITH VALIUM® 2 mg TABLET (2 mg DIAZEPAM) MANUFACTURED BY F. HOFFMANN-LA ROCHE AG, SWITZERLAND FOR WAYLIS THERAPEUTICS LLC, USA AND NOVALGIN® CAPLET (500 mg METAMIZOLE SODIUM) MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA FOR PT KALVENTIS SINERGI FARMA, INDONESIA IN HEALTHY SUBJECTS |
|
| INA-TZKCGK6 |
Complete
|
Bioequivalence study of Ladenum (Lansoprazole 30 mg) delayed release capsule produced by PT Imedco Djaja in Comparison with Takepron® 30 (Lansoprazole 30 mg) delayed release capsule manufactured by Takeda Teva Pharmaceutical Co., Ltd., Osaka, Japan, distributed by Takeda Pharmaceutical Co., Ltd.
|
| INA-BFL2BY1 |
Complete
|
Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT Combiphar in Comparison with Movicox(R) 15 mg Tablet Manufactured by PT. Boehringer Ingelheim Indonesia.
| Interventions: |
Meloxicam 15 mg Tablet |
|
| INA-68LT8NW |
Complete
|
BIOEQUIVALENCE STUDY OF KETOPROFEN 100 MG SUPPOSITORIES MANUFACTURED BY PT COMBIPHAR IN COMPARISON WITH PROFENID® 100 MG SUPPOSITORIES MANUFACTURED BY PT AVENTIS PHARMA, INDONESIA
| Interventions: |
Profecom 100 mg suppositories |
|
| INA-OQMWAGS |
Complete
|
Bioequivalence study of Amlodipine 10 mg tablet, Gravask® manufactured by PT Graha Farma in comparison with Amlodipine 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Amlodipine 10 mg tablet, Gravask® manufactured by PT Graha Farma |
|
| INA-4RAGD7G |
Initial
|
Bioequivalence Study of Gabapentin 300 mg capsule, GRASA-300® manufactured by PT Gracia Pharmindo 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
|
| INA-E1RAR8P |
Initial
|
BIOEQUIVALENCE STUDY OF LOXIL 15 MG TABLET MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH MOBIC® 15 MG TABLET MANUFACTURED BY ROTTENDORF PHARMA GMBH, GERMANY, MARKETING AUTHORIZATION HOLDER BY BOEHRINGER
|
| INA-B793ENB |
Complete
|
Bioequivalence Study of Celecoxib 200 mg (Celixa® 200) Capsule Manufactured by PT Interbat in Comparison with Celebrex® 200 mg Capsule Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Imported by PT Pfizer Indonesia - Indonesia
| Interventions: |
Celixa® 200 Capsule |
|
| INA-Y77M0HO |
Complete
|
Bioeqivalence study of Escitalopram 20 mg film coated caplet manufactured by PT Mersifarma Tirmaku Mercusana In comparison with Escitalopram 20 mg film coated tablet Cipralex® manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark; Registered by PT Pyridam Farma, Tbk, Jakarta, Indonesia
| Interventions: |
Escitalopram 20 mg film coated caplet, manufactured by PT Mersifarma Tirmaku Mercusana |
|
| INA-EXER6KO |
Complete
|
Bioequivalence study of 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica in comparison with the innovator film-coated tablets (Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France).
| Interventions: |
Test drug: 850 metformin hydrochloride film-coated tablet produced by PT Dexa Medica
Reference drug: Glucophage® 850 mg, PT Merck, Tbk, Jakarta, under license from Merck Sante SAS, France |
|
| INA-D6RYET3 |
Complete
|
BIOEQUIVALENCE STUDY OF RETAPHYL (THEOPHYLLINE) 300 MG SUSTAINED RELEASE CAPLET PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (NUELIN™-SR 300 SUSTAINED RELEASE TABLET PRODUCED BY ADCOCK INGRAM LIMITED, INDIA FOR INOVA PHARMACEUTICALS (S) PTE LTD) WHEN ADMINISTERED UNDER FASTING CONDITION IN HEALTHY SUBJECTS
| Interventions: |
Retaphyl SR tablet 300 mg manufactured by PT Kimia Farma Tbk |
|
| INA-75TD4ON |
Recruit
|
The Effectiveness of Back Massage Using Virgin Coconut Oil and White Petroleum Jelly To Prevent Pressure Sores
| Interventions: |
Nursing care carried out includes data analysis, nursing diagnoses, nursing interventions, nursing implementation and nursing evaluation. The non farmakologist intervention carried out in this study was Slow Stroke Back Massage with Virgin Coconut Oil which was carried out for 5 days with an application time of 10-20 minutes in accordance with evidance based nursing. |
|
| INA-6ATA2X3 |
Initial
|
PICTURE EXCHANGE COMMUNICATION SYSTEM VERSUS VIDEO MODELING IN IMPROVING ORAL HYGIENE OF CHILDREN WITH AUTISM SPECTRUM DISORDER
| Interventions: |
The research will begin with making pictures of the steps of brushing teeth according to the PECS method and making videos of how to brush teeth according to VM which will be used as an intervention in the study. Next, the researcher will make a pre-test and post-test to determine parents' understanding of the intervention. After making the pre-post test, the researcher will group the research subjects into two intervention groups. Next, the researcher will submit informed consent to parents with ASD children who will become research samples. Parents who have signed the informed consent will be given a pre-test. Next, parents will be given material about the use of PECS or VM. After giving the material, researchers will distribute a post-test to parents to assess the extent to which parents understand the use of PECS or VM. The results of this test are used to assess parents' understanding and readiness to provide tooth brushing instruction to children so that the intervention can run well.
After the parents'/caregivers' understanding of the intervention has been assessed, the researcher will collect subjective assessments from parents about the child's tooth brushing process using a checklist, conduct an objective assessment of the child's tooth brushing ability using a checklist, and check the child's oral hygiene with the Oral Hygiene Index before the intervention is carried out. Furthermore, PECS pictures and VM videos were given to the research subjects. Seti |
|
| INA-0ZFOKKN |
Recruit
|
The Using of Centella Asiatica Cream 2.5% with Ceramide Cream in the Mild-Moderate Children Atopic Dermatitis Patients
| Interventions: |
centella asiatica cream 2,5%, topical, 2 times daily, for 4 weeks, in right and left arm |
|
| INA-X2TDF9A |
Complete
|
Bioequivalence study of ketoconazole 200 mg tablet produced by PT Beta Pharmacon for PT Dexa Medica in comparison with the comparator drug (Ketoconazole® 200 mg Tablet produced by Taro Pharmaceuticals Industries Ltd., Israel distributed by Taro Pharmaceuticals U.S.A., Inc.) when administered under fasting condition in healthy subjects.
| Interventions: |
Test drug: ketoconazole 200 mg tablet produced by PT Beta Pharmacon for PT Dexa Medica Reference drug: Ketoconazole® 200 mg Tablet produced by Taro Pharmaceuticals Industries Ltd., Israel distributed by Taro Pharmaceuticals U.S.A., Inc.) |
|
| INA-PBCQLNK |
Complete
|
Bioequivalence study of terazosin hydrochloride 2 mg tablet produced by PT Dexa Medica in comparison with the comparator drug (Hytrin® 2 mg Tablet produced by Aesica Queenborough Limited, UK) when administered under fasting condition in healthy subjects.
|
| INA-D5SG9O4 |
Complete
|
Bioequivalence study of alprazolam 1 mg tablet produced by PT Dexa Medica in comparison with the comparator drug of Xanax® 1 mg Caplet, produced by Pfizer Pharmaceutical LLC, Puerto Rico, packed and released by Pfizer Italia S.r.l., Italy, registerd by PT Pfizer Indonesia, Indonesia in healthy subjects under fasting conditions.
|
| INA-XEFXO4Z |
Complete
|
bioequivalence study of Amlodipine-Valsartan 10/160 mg Film Coated Caplet, Dioforge manufactured by PT Lloyd Pharma Indonesia in comparison with Amlodipine-Valsartan 10/160 mg Film Coated Tablet, Exforge manufactured by Siegfried Barbera S.L Barbera del Valles, Barcelona, Spain; for Novartis Pharma AG, Basel, Switzerland; imported by PT Novartis Indonesia
| Interventions: |
Amlodipine-Valsartan 10/160 mg Film Coated Caplet, Dioforge manufactured by PT Lloyd Pharma Indonesia |
|
| INA-ANR5X95 |
Complete
|
BIOEQUIVALENCE STUDY OF PYRAZINAMIDE 500 MG TABLET MANUFACTURED BY PT KIMIA FARMA TBK IN COMPARISON WITH PYRAFAT® 500 MG FILM-COATED TABLET MANUFACTURED BY SW PHARMA GMBH, GERMANY
| Interventions: |
PYRAZINAMIDE 500 MG TABLETS MANUFACTURED BY PT KIMIA FARMA TBK |
|
| INA-BMNH7YZ |
Complete
|
Bioequivalence Study of Amlodipine besylate 10 mg tablet, A-B Vask® manufactured by PT Lapi Laboratories in comparison with Amlodipine besylate 10 mg tablet, Norvask® manufactured by PT Pfizer Indonesia
| Interventions: |
Amlodipine besylate 10 mg tablet, A-B Vask manufactured by PT Lapi Laboratories |
|
| INA-4KRGNHZ |
Complete
|
THE EFFECT OF PROBIOTIC SUPPLEMENTATION ON THE DEGREE OF DEPRESSION, ANXIETY, AND STRESS IN CANCER PATIENTS WITH CHEMOTHERAPY
(SEROTONIN BIOMARKER ANALYSIS)
| Interventions: |
The intervention group received probiotics (Lactobacillus rhomnosus Rosell-11 and Lactobacillus helveticus Rosell-52 at a dose of 2x109 CFU) twice a day for 8 weeks. |
|
| INA-PXSYM1M |
Complete
|
Bioequivalence study of sitagliptin/metformin 50 mg/500 mg extended release tablet produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in comparison with the comparator drug (Janumet® XR 50 mg/500 mg Extended Release Tablet produced by MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico, registered by PT Organon Pharma Indonesia Tbk., Indonesia) when administered under fasting condition in healthy subjects.
|
| INA-OKQAYOS |
Complete
|
BIOEQUIVALENCE STUDY OF TWO ZIDOVUDINE 100 MG CAPSULE FORMULATIONS PRODUCED BY PT KIMIA FARMA TBK. IN COMPARISON WITH THE COMPARATOR DRUG (RETROVIR® 100 MG CAPSULE, PRODUCED BY GLAXOSMITHKLINE PHARMACEUTICALS S.A., POLAND FOR VIIV HEALTHCARE BV, NETHERLANDS)
| Interventions: |
ZIDOVUDINE 100 MG CAPSULE (IN HEALTHY SUBJECT) |
|
| INA-KYQ956C |
Complete
|
Bioequivalence study of Aciclovir 400 mg Tablet manufactured by PT Bernofarm in comparison with Aciclovir 200 mg Tablet, Zovirax manufactured by Glaxo Wellcome S.A., Aranda, Spain; imported by PT Glaxo Wellcome Indonesia
| Interventions: |
Aciclovir 400 mg Tablet manufactured by PT Bernofarm |
|
| INA-Z6F3MD9 |
Complete
|
Bioequivalence study of Candesartan Cilexetil 16 mg Tablet, Candefar manufactured by PT Pratapa Nirmala in comparison with Candesartan Cilexetil 16 mg Tablet, Blopress manufactured by PT Takeda Indonesia, Under license by Takeda Pharmaceutical Company Limited, Osaka, Japan
| Interventions: |
Candesartan Cilexetil 16 mg Tablet, Candefar manufactured by PT Pratapa Nirmala |
|
| INA-5R3E0FH |
Complete
|
Bioequivalence study of Trizidip MR (Trimetazidine Dihydrochloride 35 mg) film coated tablet produced by PT Dipa Pharmalab Intersains in Comparison with Trizedon® MR (Trimetazidine Dihydrochloride 35 mg) film coated tablet manufactured by PT Darya-Varia Laboratoria Tbk, Bogor – Indonesia, under license Les Laboratoires Servier, France.
|
| INA-NYFZ1AL |
Recruit
|
Bioequivalence study of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. in comparison with the comparator drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia)
| Interventions: |
The present study was conducted to find out whether the bioavailability of pramipexole dihydrochloride monohydrate 0.75 mg extended release tablet produced by PT Darya-Varia Laboratoria Tbk. was equivalent to the comparator’s drug (Sifrol® ER 0.75 mg Extended Release Tablet produced by Boehringer Ingelheim Pharma GmbH & Co. KG, Germany, for Boehringer Ingelheim International GmbH, Germany, imported by PT Boehringer Ingelheim Indonesia, Indonesia) when administered under fasting condition in healthy subjects. |
|
| INA-2EAQA8E |
Complete
|
Bioequivalence study of 5 mg Donepezil Hydrochloride (Aldomer 5) Film Coated Tablets Produced by PT. Mersifarma Tirmaku Mercusana in Comparison with Aricept 5 mg Film Coated Tablets Manufactured by Eisai Co., Ltd. Japan
| Interventions: |
Donepezile Mersifarma |
|
| INA-5RCZKFT |
Recruit
|
Effectiveness of Spiritual Audio Therapy on Anxiety and Sleep Quality in Hemodialysis Patients: A Randomized Controlled Trial
| Interventions: |
In the intervention group, the intervention of audio dzikir asmaul husna and sholawat Tibb'il Qulub was given 4 times per week (on Monday, Wednesday, Friday, and Sunday), implemented for 2 weeks, each meeting lasted ± 20-30 minutes. The intervention of listening to dhikr and sholawat by listening through MP3 and headset |
|
| INA-Z062LMG |
Complete
|
Bioequivalence study of Pantoprazole 40 mg enteric coated tablet, Pantopump® manufactured by PT Interbat in comparison with Pantoprazole 40 mg gastro-resistant tablet, Pantozol® manufactured by Takeda GMBH, Germany, imported by PT Takeda Indonesia
| Interventions: |
Pantoprazole 40 mg enteric coated tablet, Pantopump® manufactured by PT Interbat |
|
| INA-3P01RP1 |
Complete
|
Bioequivalence study of Amlodipine 10 mg caplet manufactured by PT. Sejahtera Lestari Farma in comparison with Amlodipine 10 mg tablet, Norvask manufactured by Pfizer Indonesia
| Interventions: |
Amlodipine 10 mg caplet manufactured by PT. Sejahtera Lestari Farma |
|
| INA-W525Q3H |
Complete
|
bioequivalence study of Sitagliptin 100 mg Film Coated Tablet, Sitavia 100 manufactured by PT Lloyd Pharma Indonesia in comparison Sitagliptin 100 mg Tablet, Januvia™ manufactured by Merck Sharp & Dohme Ltd., Cramlington, England; Registered and Packed by PT Organon Pharma Indonesia Tbk; Distributed by PT Merck Sharp & Dohme Indonesia
| Interventions: |
Sitagliptin 100 mg Film Coated Tablet, Sitavia 100 manufactured by PT Lloyd Pharma Indonesia |
|
| INA-N2GZH4H |
Recruit
|
Effectiveness of Stroke Self-Management Education on Knowledge, Self-Efficacy, and Self-Management Behavior in Post-Stroke Patients: A Randomized Control Trial
| Interventions: |
We provided an intervention in the form of stroke self-management education using lecture and audio-visual methods through booklets and smartphones. The SSME booklet contains guidelines for the implementation of SSME during the study period, including the initial explanation of the study, program objectives, SSME program rules, SSME program timeline, series of activities, and SSME materials.
The SSME programs that will be provided are recurrent stroke management, coping management, nutrition and activity, social support and problem-solving strategies, and the patient's independent phase. This program has been modified according to the needs of respondents, implemented for three weeks with five online meetings. |
|
| INA-Q1YNOYZ |
Complete
|
bioequivalence study of Azithromycin 500 mg film coated caplets, manufactured by PT Sampharindo Perdana in comparison with 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, manufactured by PT Sampharindo Perdana |
|
| INA-FCC1QET |
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
|
| 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
|
| 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.
|
| 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.
|
| 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.
|
| 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.
|
| 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.
|
| 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
|
| 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
|
| 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
|
| 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)
|
| 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 |
Complete
|
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
|
| 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
|
| 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
|
| 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.
|
| 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
|
| 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 |
Complete
|
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
|
| 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
|
| 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
|
| 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. |
|
| |
|
|
| 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.
|
| INA-K9B06PS |
Complete
|
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.
|
| 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
|
| 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
|
| 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 |
Complete
|
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 |
Complete
|
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 film coated 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
|
| 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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
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) dan Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) |
|
| INA-HB8C9XD |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 |
Complete
|
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 | |