Single-dose randomized, open-label, 2-way crossover bioequivalence study of clopidogrel 75 mg tablet in healthy volunteers under fasting conditions

Aim This study aimed to assess the bioequivalence of 2 formulations of 75 mg clopidogrel hydrogen sulphate film-coated tablet, Under fasting conditions. Subjects and methods: 64 healthy subjects, age ranging from 19 to 55 years, were enrol led in a single-centre, randomized, single-dose, open-label, 2-way crossover Study, with a minimum washout period of 7 days. Plasma samples were collected LIP to 24 h post dosing. Clopidogrel and clopidogrel carboxylic acid levels were determined by reverse-phase high-performance chromatography coupled to tandem mass spectrometry detection, LC-MS-MS method. Pharmacokinetic parameters used for bioequivalence assessment were the AUC(last) (area under the concentration-time curve from time zero to time of last observed nonzero concentration) and the C-max (maximum observed concentration). These parameters were determined from the clopidogrel concentration data using non-compartmental analysis as well for clopidogrel carboxylic acid concentration data. Results: The 90% CI (90% confidence intervals), obtained by analysis of variance (ANOVA) were within the predefined ranges (80.00 - 125.00%) for both analytes. Conclusion: Bioequivalence between test and formulations, under fasting conditions, was Concluded both in terms of rate and extent of absorption.