Bioequivalence study of Palva® (Sildenafil 20 mg) film coated tablet produced by PT Dipa Pharmalab Intersains in comparison with Revatio® (Sildenafil 20 mg) film coated tablet manufactured by Fareva Amboise, Pocé-sur-Cisse, France, imported by PT Pfizer Indonesia, Jakarta, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Dipa Pharmalab Intersains
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-1QZP0PD0
Tanggal Input Registry : 14-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 07-10-2024 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Palva® (Sildenafil 20 mg) film coated tablet produced by PT Dipa Pharmalab Intersains in comparison with Revatio® (Sildenafil 20 mg) film coated tablet manufactured by Fareva Amboise, Pocé-sur-Cisse, France, imported by PT Pfizer Indonesia, Jakarta, Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence study of Palva® (Sildenafil 20 mg) film coated tablet produced by PT Dipa Pharmalab Intersains in comparison with Revatio® (Sildenafil 20 mg) film coated tablet manufactured by Fareva Amboise, Pocé-sur-Cisse, France, imported by PT Pfizer Indonesia, Jakarta, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Not Specified |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign the informed consent; Age 18 – 55 years; Body mass index between 18 – 25 kg/m2; Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 90 beats per minute; Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination).Exclusion Criteria: Contraindicated and/or has history of hypersensitivity to Sildenafil or related drug; With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or cardiovascular disease; Show abnormal result or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result; Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day; Participated in any clinical study within 3 months prior to the study; Donated or lost 300 mL (or more) of blood within 3 months prior to the study; Smoke more than 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; With the history of alcohol and drug abuse; Indicate the positive result on test for HbsAg, Anti-HCV, and anti-HIV; pregnant or lactating female (urinary pregnancy test applied to female subject at screening and before taking the study drug); To reduce the risk of Covid-19 transmission, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days; With history or present sore throat, fever (temperature more than 37°C) or short of breath within last 14 days; Positive to Covid-19 antigen rapid test, for those who do not yet receive a complete primary vaccination against Covid-19 and at least the forst booster. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-1075/ UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 208/FORM/OMF/2024 ver 00 Report No. 160/RPT/OMF/2024 ver 00 |
| Contact Person | apt. Kireyne E SItanggang, S.Farm |