Clinical trials: Indonesia
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
A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64
The purpose of the study is to characterize the immunogenicity \& safety of 2 doses of GSK's avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years
- Trial name
- NCT00695669
- Testing
- Influenza A (H5N1) Virus Monovalent Vaccine
- Where
- 3 sites in Canada
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Malaria
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring…
- Trial name
- NCT03503058
- Testing
- PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis, Normal Saline
- Where
- 2 sites in Indonesia
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Healthy
Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets
The present study was a randomized, open-label, two-period, two-sequence, cross-over study, conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa Medica (test drug) was bioequivalent to the…
- Trial name
- NCT03422575
- Testing
- Etoricoxib 120Mg Film-coated Tablet, Arcoxia® 120 mg Film-coated tablet (Frosst Iberica S.A., Spain for Merck Sharp & Dohme (Australia) Pty Limited, Australia, registered by PT. Schering-Plough Indonesia Tbk)
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
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
Drug Use
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT.
- Trial name
- NCT04988646
- Testing
- Acyclovir 200 MG, Acyclovir 400 MG, Zovirax 200 MG Tablet
- Where
- Indonesia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
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
Diabetes, Diabetes Mellitus, Type 1
NovoLet® Surveillance Study on Using Human Insulin System in Indonesia
This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT01492153
- Testing
- biphasic human insulin, isophane human insulin, human soluble insulin
- Where
- Indonesia
- Volunteers
- 1,981 people
- Sponsor
- Novo Nordisk A/S
Diabetes, Diabetes Mellitus, Type 1
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in Indonesia
This study is conducted in Asia. The aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in Asia.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- DiabCare Asia (NCT00788853)
- Testing
- No treatment given
- Where
- Indonesia
- Volunteers
- 1,832 people
- Sponsor
- Novo Nordisk A/S
Pneumococcal Vaccines, Pneumococcal Infections
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine…
- Trial name
- NCT06608199
- Testing
- pneumococcal disease prevention
- Where
- 3 sites in Indonesia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd
Breast Cancer Female, Stage II Breast Cancer
Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.
- Conditions
- Breast Cancer Female, Stage II Breast Cancer, Stage III Breast Cancer, HER2-positive Breast Cancer
- Trial name
- BRAVA (NCT06087120)
- Where
- 3 sites in Indonesia, Vietnam
- Volunteers
- 125 people
- Sponsor
- Gene Solutions
Diabetes, Diabetes Mellitus, Type 1
NovoLet® Acceptance Study Within the Hospital Practise in Indonesia
This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT01492205
- Testing
- insulin human
- Where
- Indonesia
- Volunteers
- 203 people
- Sponsor
- Novo Nordisk A/S
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ (ECOS Taiwan, Indonesia, Singapore)
This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level…
- Trial name
- ECOS TW ID SG (NCT02015273)
- Testing
- easypod™
- Where
- 6 sites in Indonesia, Singapore and 1 more
- Volunteers
- 82 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
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.
Overactive Bladder
A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
- Trial name
- RESORT-2 (NCT01122563)
- Testing
- Solifenacin
- Where
- 3 sites in Indonesia
- Volunteers
- 55 people
- Sponsor
- Astellas Pharma Inc
Diabetes, Diabetes Mellitus, Type 2
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.
- Trial name
- DiabCare Asia (NCT02066766)
- Testing
- No treatment given
- Where
- Vietnam
- Volunteers
- 1,631 people
- Sponsor
- Novo Nordisk A/S
COVID-19
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people.
- Trial name
- NCT05621239
- Testing
- BNT162b2
- Where
- Indonesia
- Volunteers
- 260 people
- Sponsor
- Pfizer
COVID-19
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
- Trial name
- NCT05313035
- Testing
- SARS-CoV-2 protein subunit recombinant vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma