Clinical Research Registry

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  Awal   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  Awal   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  Awal   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  Awal   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 
  Awal   NA 
Interventions: Pemberian obat uji dilakukan setelah puasa minimal 10 jam semalam. 
INA-HAWRFA8  Awal   BDB-001 
Interventions: a. Treatment group: conventional treatment + BDB-001 Injection b. Control group: conventional treatment 
INA-N2ZX642  Awal  
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  Awal   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  Awal   ARCoV-005 
Interventions: Vaksin Aktif ARCoV : Placebo/ Normal Saline dengan perbandingan 1:1 
INA-WCMM  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   Implant 1 Batang Etonogestrel 
Interventions: Kesulitan dalam pencarian subjek yang bebas hormonal selama 3 bulan. 
INA-CY27H  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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