Bioequivalence study of 100 mg Sildenafil Citrate Film Coated Tablets Manufactured by PT. Prima Medika Laboratories (Rozgra®) In Comparison with the Innovator’s 100 mg Sildenafil Citrate Film Coated Tablets (Viagra®), Manufactured by Fareva Ambiose, Poce-sur-Cisse, France, Imported by PT. Pfizer Indonesia, Jakarta, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Prima Medika Laboratories
Mitra Pelaksana:
Econolab
No Registry
INA-BC98F9Y
Tanggal Input Registry : 06-02-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 19-09-2022 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-Inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of 100 mg Sildenafil Citrate Film Coated Tablets Manufactured by PT. Prima Medika Laboratories (Rozgra®) In Comparison with the Innovator’s 100 mg Sildenafil Citrate Film Coated Tablets (Viagra®), Manufactured by Fareva Ambiose, Poce-sur-Cisse, France, Imported by PT. Pfizer Indonesia, Jakarta, Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence study of 100 mg Sildenafil Citrate Film Coated Tablets Manufactured by PT. Prima Medika Laboratories (Rozgra®) In Comparison with the Innovator’s 100 mg Sildenafil Citrate Film Coated Tablets (Viagra®), Manufactured by Fareva Ambiose, Poce-sur-Cisse, France, Imported by PT. Pfizer Indonesia, Jakarta, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | single dose of 100 mg Sildenafil Citrate (Rozgra@), Manufactured by PT Prima Medika Laboratories |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male subjects as determined by the medical screening assessments; Aged 18-55 years of age; 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 have to be within normal range.Exclusion Criteria: Known hypersensitivity or contraindication to the study drug; intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any prior allergic drug rash; 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 300 mL (or more) of blood within 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 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day); Clinically have significant bleeding within 3 months prior to the study; Participation in a previous study within 3 months of this study’s first dosing day; A positive nasopharyngeal swab SARS-CoV2 (Covid-19) antigen rapid test result. Covid-19 antigen rapid test to be applied to all subjects when screening and one day before drug administration in each period of study. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-124/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-261/21/ECL |
| Contact Person | Ni Made Dwi Wulandari |