Authors

Priyanto^1,2, Wahyono BH¹, Widiastuti E¹, Susilo MJ¹, Yunica NT¹, Pudjiati DJ³, and Reflinda Y³, ¹Equitrust Lab, Jakarta, Indonesia, ²University of Muhammadiyah Prof. Dr. HAMKA, Indonesia, ³PT Kimia Farma tbk, Indonesia

Abstract

The objective of this study was to determine the bioequivalence of Ethambutol 400 mg Film-Coated Tablet produced by PT Kimia Farma Tbk compared to the WHO-recommended comparator product, Myambutol 400 mg Film-Coated Tablet produced by Pantheon Inc, Ontario, Canada for STI Pharma LLC, in healthy subjects. The study design used was a randomised two-way crossover design, single dose, open label, under fasting conditions. The number of subjects who completed the study was 29 of 32. Blood samples were collected 18 times. Ethambutol concentrations were determined by LC-MS/MS method. 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 results of the statistical analysis for the bioequivalence study comparing the test drug to the comparator drug showed a geometric mean ratio (90% CI) of 103.67% (97.23-110.52%) for the area under the concentration-time curve (AUC0-t) and 91.53% (84.80-98.79%) for the maximum concentration (Cmax). Based on the result, the test drug is bioequivalent to the comparator drug.

Keywords

Ethambutol, AUC, Bioequivalence, Comparator, and Crossover