Saudi Journal of Medical and Pharmaceutical Sciences (SJMPS)
Volume-11 | Issue-01 | 31-36
Original Research Article
Bioequivalence Study of Two Formulations of Clopidogrel Tablets under Fasting Conditions in Healthy Adult Subjects
Nisha Rajendran, Gunasakaran Sambandan, PGM Adam Rafi, Vivek Partheeban
Published : Jan. 16, 2025
Abstract
Clopidogrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of Adenosine Diphosphate (ADP) receptors on platelets. This study compared the pharmacokinetics and safety profiles of a new generic formulation of clopidogrel tablets with those of the branded reference formulation in healthy subjects under fasting conditions. The bioequivalence study was conducted as an open-label, randomized, two-treatment, three sequence, three period, single dose, crossover, semi-replicate, bioequivalence study of Clopidogrel Coated Tablets, 75 mg of Caplin Point Laboratories Ltd., India and PLAVIX (Clopidogrel) Coated Tablets, 75 mg of Sanofi-Aventis de Chile S.A. in healthy, adult, human subjects under fasting conditions. An ultra-performance liquid chromatography method with mass spectrometric detection for the determination of Clopidogrel in K2EDTA human plasma was developed and validated. The 90% confidence intervals for Ln-transformed pharmacokinetic parameters - Cmax, AUC0-t, and AUC0-∞ were 90.09 - 125.12%, 85.23 - 111.62% and 82.93 - 104.30% respectively for Clopidogrel, where Cmax is within the acceptable limit of widen range 73.18 – 136.65% as per the obtained Intrasubject Coefficient of Variation (ISCV) of reference formulation and AUC0-t and AUC0-∞ are within the acceptance limit of 80.00 - 125.00%. Hence, based on the ln-transformed results of Cmax, AUC0-t and AUC0-∞, it is concluded that the test product (Clopidogrel Tablets USP 75 mg of Caplin Point Laboratories Ltd., India) is bioequivalent to reference (PLAVIX [Clopidogrel Tablets 75 mg] of Sanofi-Aventis de Chile S.A.) in healthy, adult, subjects under fasting conditions.