Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT Pharos Indonesia (Profibrat) in Comparison with the Innovator's Capsules (Lipanthyl), Manufactured by Recipharm Fontaine, France, Imported and Repacked by PT Combiphar, Bandung, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Pharos Indonesia
Mitra Pelaksana:
Econolab
No Registry
INA-4H6FAA3
Tanggal Input Registry : 27-05-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 03-03-2017 |
| Outcome Primer | AUC0-t, Cmax |
| Outcome Skunder | AUC0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT Pharos Indonesia (Profibrat) in Comparison with the Innovator's Capsules (Lipanthyl), Manufactured by Recipharm Fontaine, France, Imported and Repacked by PT Combiphar, Bandung, Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT Pharos Indonesia (Profibrat®) in Comparison with the Innovator's Capsules (Lipanthyl®), Manufactured by Recipharm Fontaine, France, Imported and Repacked by PT Combiphar, Bandung, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 200 mg Fenofibrate Capsules (Profibrat®), Manufactured by PT Pharos Indonesia |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to communicate well with the investigators and agree to sign an informed consent; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years; Body mass index (BMI) is in the range of 18-25 kg/m²; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); Normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results must be within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test were applied to female subjects when screening and just before taking the test or reference drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within seven (7) days of this study’s first dosing day; History of any bleeding, or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 450 mL (or more) of blood within three (3) months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within twelve (12) months prior to the study; Heavy smoker (more than 10 cigarettes a day); Had clinically significant bleeding within three (3) months prior to the study. |
| Administrative Information | |
| Nomor Persetujuan Etik | 86/UN2.F1/ETIK/I/2017 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-207/16/ECL |
| Contact Person | Ni Made Dwi Wulandari |