Clinical Research Registry

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  Awal   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. 
  Awal   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. 
  Awal   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  Awal   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  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 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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   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  Awal   : 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  Awal   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  Awal   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  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