Bioequivalence Study of Two Etoricoxib 90 mg Film-Coated Tablet Formulations

Abstract

The present study was conducted to compare the bioavailability of two etoricoxib 90 mg film-coated tablet formulations (test formulation and reference formulation). This study was an open-label, randomized, single-dose, two-periods, twotreatments, and crossover study which included 24 healthy adult male and female subjects under fasting conditions. Each of the two study periods was separated by a 7 days washout. A single dose of test or reference drug was administered to the subject in each period based on the randomization scheme. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 96 h (AUC0-96h), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (Tmax), and the elimination half-life (T1/2). The geometric mean ratios (90% CI) of the test drug/reference drug for etoricoxib were 102.39% (97.63% – 107.38%) for AUC0-96h and 93.23% (86.54% – 100.43%) for Cmax. The 90% Confidence Intervals (CI) calculated for AUC0-96h and Cmax of etoricoxib were within the standard bioequivalence range (80.00– 125.00% for AUC0-t and Cmax). It was concluded that the two etoricoxib film-coated tablets (test and reference drug) were bioequivalent in terms of the rate and extent of absorption