Abstract

The purpose of this study was to assess bioequivalence of two marketed formulations of celecoxib capsules in healthy human male volunteers. The study was conducted according to a single dose, randomized sequence, open label, two-period and crossover design. Both test and reference formulations comprised labeled dose of 200 mg celecoxib and were administered to each subject after an overnight fasting on two treatment days separated by one week of washout period. After drug administration, blood samples were collected at predetermined time points for a period of 48 h. Plasma separated from blood was analyzed for celecoxib concentrations using validated reverse phase-high performance liquid chromatographic (RP-HPLC) method. Various pharmacokinetic parameters including C_max, T_max, AUC_0-t, AUC_0-∞, T_1/2 and K_el were determined from the plasma concentration for both formulations. C_max, AUC_0-t and AUC_0-∞, were evaluated for bioequivalence after log-transformation of data. The 90% confidence intervals for the ratio of C_max (93.26 to 100.70%), AUC_0-t (87.00 to 117.50%) and AUC_0-∞ (86.49 to 118.56%), values for the test and reference products were within the acceptance range of 80 to 125%, proposed by Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Based on these statistical inferences, it was concluded that two formulations of celecoxib are bioequivalent in their rate and extent of absorption.

Key words: Celecoxib, pharmacokinetics, bioequivalence, healthy human male volunteers.