Pharmacokinetic Evaluation of Amlodipine Tablet Compared with Norvask® Tablet in Healthy Indonesian Adults


Authors

Priyanto1,2, Yunica NT1, Widiastuti E1, Wahyono BH1, Susilo MJ1, Siregar P3, Mutiawati Y3, and Kancanawatie DG3, 1Equitrust Lab, Indonesia, 2University of Muhammadiyah Prof. Dr. HAMKA, Indonesia, 3PT Tropica Mas Pharmaceuticals, Indonesia

Abstract

This study objective to evaluate the pharmacokinetics of Amlodipine 10 mg Produced by PT. Tropica Mas Pharmaceuticals compared to Norvask® 10 mg Tablet Produced by PT. Pfizer Indonesia, in healthy Indonesian Adults through bioequivalence study. This study is utilized by randomized, single-dose, open-label, two-way cross-over design with a washout period 14 days and fasting. This study involved 18 subjects, with only 17 subjects included in the statistical analysis, because 1 subject withdrew due to diarrhoea in the 2nd period. Plasma samples were collected 17 times for 72-hour per period. Amlodipine concentrations were measured using LCMS/MS. Bioequivalence was determined by value of 90% confidence interval (CI) with α = 5.00% within the range of 80.00–125.00% for AUC and Cmax. The geometric mean ratios (90% CI) of the test drug vs. the innovator drug were 101.67% (97.16 – 106.39) for AUC0-t and 100.46% (95.00 – 106.23) for Cmax. Based on the result, the test drug is bioequivalent to the comparator drug.

Keywords

Pharmacokinetic, Bioequivalence, Amlodipine, AUC, and Two-Way Crossover