Bioequivalence Study of 20 mg Tadalafil Film Coated Tablets Produced by PT Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly del Caribe Inc., Puerto Rico, Packed and Released by Lilly S.A., Spain, Registered by PT Pyridam Farma Tbk., Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT NOVELL PHARMACEUTICAL LABORATORIES
Mitra Pelaksana:
NA
No Registry
INA-DRXBBXT
Tanggal Input Registry : 13-11-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 08-05-2023 |
| Outcome Primer | AUC0-t, AUC0-∞ and Cmax |
| Outcome Skunder | T1/2 dan Tmax |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 20 mg Tadalafil Film Coated Tablets Produced by PT Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly del Caribe Inc., Puerto Rico, Packed and Released by Lilly S.A., Spain, Registered by PT Pyridam Farma Tbk., Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 20 mg Tadalafil Film Coated Tablets Produced by PT Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly del Caribe Inc., Puerto Rico, Packed and Released by Lilly S.A., Spain, Registered by PT Pyridam Farma Tbk., Indonesia |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 24 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Gave a written informed consent; Healthy subjects, male, age between 18 to 55 years old; Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2); Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm); Acceptable medical history and physical examination; Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR); Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine; Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria); Normal cardiovascular function proven by electrocardiogram (ECG) result; Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV); Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine; Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID-19 pandemic (were done for all subject at screening)Exclusion Criteria: Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted; Had history of hepatic, cardiovascular, gastrointestinal or renal disease; Consumed any form of organic nitrate (e.g., oral, sublingual, transdermal, by inhalation), either regularly and/or intermittently; Hypersensitivity to tadalafil or similar medication; Had history or condition of myocardial infarction; Had history or condition of unstable angina or angina occurring during sexual intercourse; Had history of New York Heart Association Class 2 or greater heart failure; Had history or condition of uncontrolled arrhythmias, hypotension ( |
| Administrative Information | |
| Nomor Persetujuan Etik | S-155.UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Edria Rasendriya |