Uji Perbandingan Kualitas Obat Selvim® 10 (Simvastatin 10 mg) dengan Obat Standar Zocor® 10 ( Simvastatin 10 mg)
Tahapan Penelitian : Complete
Sponsor:
PT IFARS Pharmaceutical Laboratories
Mitra Pelaksana:
Advanced Pharmaceutical Sciences Laboratories, Faculty of Pharmacy Universitas Gadjah Mada
No Registry
INA-GOMZ75T
Tanggal Input Registry : 10-10-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 12-02-2024 |
| Outcome Primer | The Cmax value of Selvim® 10 (Simvastatin 10 mg) was 10.63 ± 1.68 ng/mL and the Cmax value of Zocor® 10 (Simvastatin 10 mg) was 11.40 ± 1.63 ng/mL. The ratio of (Cmax)T/(Cmax)R value of both products was 93.06%. |
| Outcome Skunder | The area under curve (AUC0-t) of Selvim® 10 (Simvastatin 10 mg) was 46.32 ± 7.45 ng.hour/mL and the AUC0-t of Zocor® 10 (Simvastatin 10 mg) was 46.46 ± 7.97 ng.hour/mL. The ratio of (AUC0-t)T/(AUC0-t)R was 100.82%. |
| Descriptive Information | |
| Judul Penelitian Popular | Uji Perbandingan Kualitas Obat Selvim® 10 (Simvastatin 10 mg) dengan Obat Standar Zocor® 10 ( Simvastatin 10 mg) |
| Judul Penelitian Ilmiah | Bioequivalence Study of Selvim® 10 mg (Simvastatin 10 mg) Caplet Produced by PT IFARS Pharmaceutical Laboratories Compared with Zocor® 10 mg (Simvastatin 10 mg) Tablet Produced by Organon Pharma (UK) Limited |
| Jenis Penelitian | Interventional |
| Intervensi | |
| Jumlah Subyek Penelitian | 34 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Healthy subjects, with healthy criteria based on clinical laboratory tests which include liver function, renal function, routine blood test, urine analysis, medical history, and physical examination. - The blood pressure and heart rate are acceptable (systolic blood pressure of 100-120 mmHg, diastolic blood pressure of 60-80 mmHg, and heart rate of 60-90 bpm). - The result of the ECG examination is acceptable. - The result of HCV serology must be negative. - The result of serological tests for Hepatitis B (HBsAg) and HIV (anti-HIV) must be negative. - The result of rapid antigen COVID-19 test must be negative. - Men and women. - Age is between 18 - 44 years. - Weight is within a normal range that follows the formula: BMI = Weight (kg) / Height2 (m) = 18 - 25 - Currently not using any medication in a week before the study. - Willing to participate in the study by signing an informed consent form.Exclusion Criteria: - Pregnant and breastfeeding women - Having a contraindication or an allergy to simvastatin - Having the habit of smoking and drinking alcohol - Using the contraceptive pills - Having a history of drug and alcohol dependence - Having a medical history that may affect the pharmacokinetics of the tested drug, such as gastrointestinal chronic diseases, diarrhea, gastric surgery, kidney failure, liver dysfunction, and cardiovascular disease. - Participating in another clinical trial within 3 months before the study. - Donating or losing 300 mL (or more) of blood within 3 months before the study. |
| Administrative Information | |
| Nomor Persetujuan Etik | KE/FK/1883/EC/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Hanifah Ratna Yuliani, S.Si. |