BIOEQUIVALENCE STUDY OF AMLODIPINE 10 MG TABLET PRODUCED BY PT MAHAKAM BETA FARMA IN COMPARISON WITH NORVASK® (AMLODIPINE 10 MG) TABLET MANUFACTURED BY PT PFIZER INDONESIA.
Tahapan Penelitian : Complete
Sponsor:
PT. Mahakam Beta Farma
Mitra Pelaksana:
-
No Registry
INA-G1SOG60
Tanggal Input Registry : 04-01-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 12-08-2023 |
| Outcome Primer | From the result of study, it was concluded that Amlodipine 10 mg tablet batch number CS23010 produced by PT Mahakam Beta Farma was bioequivalent to its reference Norvask® (Amlodipine 10 mg) tablet batch number FX9585 manufactured by PT Pfizer Indonesia. |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF AMLODIPINE 10 MG TABLET PRODUCED BY PT MAHAKAM BETA FARMA IN COMPARISON WITH NORVASK® (AMLODIPINE 10 MG) TABLET MANUFACTURED BY PT PFIZER INDONESIA. |
| Judul Penelitian Ilmiah | BIOEQUIVALENCE STUDY OF AMLODIPINE 10 MG TABLET PRODUCED BY PT MAHAKAM BETA FARMA IN COMPARISON WITH NORVASK® (AMLODIPINE 10 MG) TABLET MANUFACTURED BY PT PFIZER INDONESIA. |
| Jenis Penelitian | Interventional |
| Intervensi | Bioequivalence study of Amlodipine 10 mg tablet produced by PT Mahakam Beta Farma in comparison with Norvask® (Amlodipine 10 mg) tablet manufactured by PT Pfizer Indonesia. |
| Jumlah Subyek Penelitian | 18 |
| 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 60- 80 mmHg), heart rate 60 – 90 beats per minute, - Healthy male (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 Amlodipin or related calcium channel blocker (nifedipine, diltiazem HCl, verapamil, or felodipine) - 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, - Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (ASL, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. - Clinically significant hematology abnormalities. - Clinically significant in the electrocardiography (ECG) test result. - Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 14 days prior to the dosing day, - Participated in any clinical study within 3 months prior the study, - Donated or lost 300 mL (or more) of blood within 3 months prior the study, - Smoke more than 9 sticks of cigarettes a day, |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-649/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 | No. 174/FORM/OMF/2023 versi 01 |
| Contact Person | apt. Noviyanto, S.Farm. |