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
Tahapan Penelitian : Complete
Sponsor:
PT Phapros Tbk
Mitra Pelaksana:
SAN-CLIN-EQ Laboratory
No Registry
INA-1ZRT75Y
Tanggal Input Registry : 12-02-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 07-09-2023 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-∞, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | 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 |
| Judul Penelitian Ilmiah | 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 |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of Gemfibrozil 300 mg Capsule, Manufactured by PT Phapros Tbk |
| Jumlah Subyek Penelitian | 18 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Voluntary agree to sign informed consent; Male and female subjects aged between 18–50 years; Normal body weight (Body Mass Index/BMI :18–25 kg/m2); Have healthy conditions based on the results of physical examination, clinical/laboratory test, and medical history; Normal blood pressure (90–129 mmHg for systolic, and 60–84 mmHg for diastolic); Normal pulse rate (60–100 bpm).Exclusion Criteria: History of hipersensitivity to gemfibrozil or other fibric acid drugs; History of stomach surgery; Heavy smoker (smoke >10 cigarettes/day); Pregnant female; Breastfeeding female; Alcohol and/or drug abuse; Impaired intestinal absorption and diarrhea; Impaired liver and renal function; Serologically positive for HBsAg, anti-HCV, and anti-HIV during health screening; Clinically significant ECG abnormalities; A donation or blood loss of 300 mL (or more) within 90 days prior to drug administration; Participation in any other bioequivalence study or clinical study within the past 90 days prior to drug administration; Consumption of any other medicines within one week prior to drug administration; Consumption of alcohol, coffee, tea, chocolate, cola, fruit juice, or carbonated drinks within 24 hours prior to drug administration and during blood sampling period; The COVID-19 antigen rapid test shows a positive result. |
| Administrative Information | |
| Nomor Persetujuan Etik | 38/UN6.KEP/EC/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | - |
| Contact Person | Rina Yuliana |