Bioequivalence and Pharmacokinetics Evaluation of Two Formulation of Febuxostat 80 Mg Tablets In Healthy Indian Adult Subject

In single center, open labeled, randomized, two-way, two-period, two-treatment, crossover, single dose bioequivalence study, test and reference formulation of Febuxostat were orally administered in twenty-six +2 (standby) healthy adult male human subjects under fasting condition, with five days washout period. Pharmacokinetic blood samples were collected periodically following drug administration. Febuxostat was measured in plasma samples by using validated high performance liquid chromatography method. The pharmacokinetics parameters Cmax, Tmax, AUC(0-t), AUC(0-∞) and Cmax/AUC (0-∞) were calculated applying noncompartmental analysis, followed by ANOVA of logarithmically transformed and untransformed values. The test versus reference ratio of geometric mean of Cmax, AUC(0-t), and AUC(0-∞) for febuxostat in both formulations were within the acceptance limit of 80120%. No adverse event or clinical significant changes were observed in any of the subjects during the two runs of the study.