Bioequivalence Study of Sildenafil 20 mg Film Coated Tablet manufactured by PT Nulab Pharmaceutical Indonesia in comparison with Sildenafil 20 mg Film Coated Tablet, Revatio® manufactured by Fareva Amboise, Pocé-sur-Cisse, France; Imported by PT Pfizer Indonesia under fasting condition.
Tahapan Penelitian : Complete
Sponsor:
PT Nulab Pharmaceutical Indonesia
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-7X6OS20M
Tanggal Input Registry : 03-09-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 13-06-2025 |
| Outcome Primer | AUC0-t , Cmax |
| Outcome Skunder | AUC0-inf , Tmax, t1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Sildenafil 20 mg Film Coated Tablet manufactured by PT Nulab Pharmaceutical Indonesia in comparison with Sildenafil 20 mg Film Coated Tablet, Revatio® manufactured by Fareva Amboise, Pocé-sur-Cisse, France; Imported by PT Pfizer Indonesia under fasting condition. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Sildenafil 20 mg Film Coated Tablet manufactured by PT Nulab Pharmaceutical Indonesia in comparison with Sildenafil 20 mg Film Coated Tablet, Revatio® manufactured by Fareva Amboise, Pocé-sur-Cisse, France; Imported by PT Pfizer Indonesia under fasting condition. |
| Jenis Penelitian | Interventional |
| Intervensi | Sildenafil 20 mg Film Coated Tablet manufactured by PT Nulab Pharmaceutical Indonesia |
| Jumlah Subyek Penelitian | 28 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: a. Willing to participate and agree to sign informed consent and communicate well with the responsible physician and study team, following all the rules and regulations set by PT Biometrik Riset Indonesia during the study. b. Healthy male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm (based on ECG examination). (ii). Respiratory Rate: 12 - 20 x/minutes. (iii).Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. (v). Body temperature < 37.5°C f. Have 12-lead ECG without significant abnormalities.Exclusion Criteria: a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Smoker or smoking more than 10 (ten) cigarettes per day. c. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. d. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. e. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. f. Known hypersensitivity or contraindication to the study drug or allied drug or other medicines, food/drinks, cold/hot weather, or other reasons. g. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g., gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. h. Clinically significant hematology and urinalysis abnormalities. i. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). j. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). k. Positive result of HBsAg, HCV, and/or HIV test. |
| Administrative Information | |
| Nomor Persetujuan Etik | S-328/UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol & Report No. 094/BE/NOV-2024 |
| Contact Person | Oktaviani Utami Dewi, S.Si - Ass. Manager QA Telp : 0853-2128-8082 e-Mail: oktaviani@biometrikriset.com |