Bioequivalence study of two clopidogrel film-coated tablet formulations in healthy volunteers

The present study was performed to compare the bioavailability of two clopidogrel 75 mg film-coated tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 24 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were assessed based on the concentrations of clopidogrel (CAS 120202-66-6) parent compound. In each of the two study periods (separated by a washout of one week) a single dose of test or reference drug was administered. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were area under the plasma concentration-time curve from time zero to 24 h (AUC(t)), area under the plasma concentration-time curve from time zero to infinity (AUC(inf)), the peak plasma concentration of the drug (C-max), time needed to achieve the peak plasma concentration (t(max)), and the elimination half life (t(1/2)). The geometric mean ratios (90% Cl) of the test drug/reference drug for clopidogrel parent compound were 95.19% (81.63-110.90%) for AUC(t), 95.55% (80.50-113.42%) for AUC(inf), and 100.18% (80.87-124.09%) for C-max The 90% confidence intervals calculated for AUC(t) and C-max of clopidogrel parent compound were within the standard bioequivalence range (80-125% for AUC and C-max). It was concluded that the two clopidogrel film-coated tablets (test and reference drug) were bioequivalent in terms of the rate and extent of absorption.