Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers

Abstract

The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers and to compare its rate and extent of absorption with the commercially available tablet Apo-Keto SR® as a reference product. The test formulation containing 20 % HPC (GXF) as release retardant was selected in this regards. The bioequivalence study was conducted according to a single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study design on six healthy non-smoking Malaysian adult male volunteers. Plasma concentrations of ketoprofen were determined by a high-performance liquid chromatographic method with UV detection. The pharmacokinetic parameters, T_max , C_max , AUC_0–∞, K_e , and T_1/2 were determined. The 90 % confidence intervals of the mean values for the test/reference ratios were 96.89-107.03 % for AUC_0–∞ and 99.64-104.62 % for C_max , respectively. The results of this study suggest that the two preparations, the test formulation of ketoprofen 200 mg tablets were bioequivalent to the marketed reference tablet of Apo-Keto SR® 200 mg in these healthy Malaysian male volunteers. However, this study results are to be further confirmed by carrying out a pivotal biostudy using more number of subjects.