Efficacy Evaluation of Meloxicam 15mg Tablet through Bioequivalence Study in Indonesian Healthy Volunteers

Abstract

Objective: The objective of this study is to compare the efficacy between the generic drug of Meloxicam 15mg Tablets produced by PT. Kimia Farma Tbk and its comparator (Movi-Cox® 15mg Tablet by PT. Boehringer Ingelheim Indonesia) by a study of bioequivalence in Indonesian healthy volunteers Methods: A randomized, single-dose, open-label, crossover two-way (2 treatments, 2 periods, and 2 sequences) under fasting condition were conducted in healthy Indonesian volunteers to evaluate bioequivalence between 2 formulations of Meloxicam 15mg tablet. This study required washout period of at least 7-days. The test and comparator drug were administered to subjects as a single oral dose. Blood samples were collected adequately (0–72 h) with 18 points to determine meloxicam concentrations in plasma using a validated LC-MS/MS analytical method. The number of subjects who participated and completed the study were 18 volunteer (9 male and 9 female). The pharmacokinetic parameters calculated in this study are AUC0-72, AUC0-inf, Cmax, tmax, and t½. The bioequivalence acceptance limit of 90% confidence interval (CI) with α = 5.00% is 80.00–125.00% for AUC and Cmax parameters. The estimation of Tmax and T½ in the bioequivalence study was based on a nonparametric statistical procedure on the original data using Wilcoxon Sign Test. Result: The results for AUC0-72 and Cmax were 108.07% (104.88-111.35) % and 105.24% (97.72-113.34) % respectively with intra-subject variability (%CV) was 5.15% for AUC0-t and 12.80% for Cmax. These results were within the regulatory acceptance limit 80.00-125.00%. Conclusion: Based on this result, it was concluded that the test formulation is bioequivalent to comparator formulation