Clinical trials: Indonesia
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Healthy
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
- Trial name
- NCT01250795
- Testing
- HAI-05 Influenza Vaccine, Saline
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
COVID-19
Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose
- Trial name
- NCT05933278
- Testing
- SARS-CoV-2 Subunit Recombinant Protein Vaccine
- Where
- Indonesia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Human Papillomavirus (HPV) Infection
Immunogenicity and Safety of HPV-4 Vaccine With or Without Td Vaccine in Children
This study will evaluate the safety and immune response of a single dose of a quadrivalent human papillomavirus (HPV) vaccine when given together with a tetanus-diphtheria (Td) vaccine in healthy children and adolescents aged 9…
- Trial name
- NCT07824310
- Testing
- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Tetanus-Diphtheria booster
- Where
- Indonesia
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
SARS-CoV2 Infection
Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
- Trial name
- COVID-19 (NCT04508075)
- Testing
- SARS-CoV-2 vaccine (inactivated)
- Where
- Indonesia
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Influenza (Pandemic)
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down into Parts A1, A2 and B.
- Trial name
- NCT01596725
- Testing
- Monovalent Avian Influenza VLP (H5N1), Monovalent Avian Influenza VLP (H5N1); Adjuvant
- Where
- 5 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Novavax
Drug Use
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT.
- Trial name
- NCT05468879
- Testing
- Glimepiride, Amaryl®
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- PT Harsen Laboratories
Drug Use
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT.
- Trial name
- NCT05753371
- Testing
- Metformin Hydrochloride 500 MG
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Pyridam Farma Tbk
Influenza
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA…
- Trial name
- NCT01147068
- Testing
- 0.5mL Intramuscular Injection
- Where
- 4 sites in United States
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- Protein Sciences Corporation
Pneumococcal Disease, Invasive
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13
The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13)…
- Trial name
- NCT05934890
- Testing
- Walvax PCV13-TT, Pfizer PCV13
- Where
- 2 sites in Indonesia
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Walvax Biotechnology Co., Ltd.
Healthy
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé…
- Trial name
- NCT03583385
- Testing
- Glucophage XR (Test drug), Glucophage XR (Comparator drug)
- Where
- Indonesia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition
The present study was conducted to find out whether the bioavailability of 10 mg lisinopril tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator (Zestril® 10 mg, PT Boehringer Ingelheim…
- Trial name
- NCT01936012
- Testing
- Lisinopril 10 mg tablets of PT Dexa Medica, Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Drug Use
Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB…
- Trial name
- NCT05849883
- Testing
- Omeprazole 20 mg Capsules
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- PT Kalbe Farma Tbk
COVID-19
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted…
- Trial name
- NCT05228613
- Testing
- SARS-CoV-2 protein subunit recombinant vaccine, SARS-CoV-2 inactivated vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Healthy
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558045
- Testing
- Rivaroxaban 20 mg film-coated tablet, Xarelto 20 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Safety Issues
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.
- Trial name
- NCT05037227
- Where
- Indonesia
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Covid19
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
- Trial name
- NCT05067894
- Testing
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, SARS-CoV-2 Inactivated Vaccine
- Where
- Indonesia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Healthy
Bioequivalence Study of Tamsulosin 0.4 mg Sustained Release Film-coated Tablets
This study was an open-label, randomized, single-dose, four-period, two-sequence, fully replicate study under fasting conditions which included 28 healthy adult male subjects.
- Trial name
- NCT06558032
- Testing
- Tamsulosin 0.4 mg Sustained Release Tablet (produced by PT Dexa Medica, Indonesia), Harnal® OCAS 0.4 mg Prolonged Release Tablet (produced by Astellas Pharma Europe B.V., The Netherlands, imported by PT Combiphar, Indonesia)
- Where
- Indonesia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Healthy
Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558058
- Testing
- Rivaroxaban 10 mg film-coated tablet, Xarelto 10 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group