Comparative Bioequivalence Study of 2 Clopidogrel 75‐mg Tablet Formulations in Moroccan Volunteers

• Published in: Clinical pharmacology in drug development 2024-09, Vol.13 (9), p.1044-1050
• Main Authors: Orche, Aimen El, Khabbaz, Choukri El, Cheikh, Amine, Bouchafra, Houda, Jawhari, Samira, Abbes, Faouzi My El, Cherrah, Yahya
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Area Under Curve; Bioequivalence; clopidogrel; Clopidogrel - administration & dosage; Clopidogrel - pharmacokinetics; Cross-Over Studies; Healthy Volunteers; Humans; Male; Moroccan volunteers; Morocco; Pharmacokinetics; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - pharmacokinetics; Tablets; Therapeutic Equivalency; Young Adult
• ISSN: 2160-763X; 2160-7648; 2160-7648
• DOI: 10.1002/cpdd.1442

This study investigates the pharmacokinetic properties and bioequivalence of 2 formulations of clopidogrel tablets administered to a cohort of healthy Moroccan male volunteers. The primary objective was to assess the rate and extent of drug absorption from the test formulation in comparison to a reference formulation, focusing on critical parameters including maximum plasma concentration (Cmax), area under the concentration‐time curve from 0 to the last measurable time (AUC0‐t), and area under the concentration‐time curve extrapolated to infinity (AUC0‐∞). The results revealed that the geometric mean ratios of Cmax, AUC0‐t, and AUC0–∞ for the test formulation relative to the reference formulation were 105.7%, 105.6%, and 105.6%, respectively. The 90% confidence intervals for these parameters fell within the predefined bioequivalence range of 80%‐125%, indicating a statistically and clinically equivalent performance between the 2 formulations. This investigation sheds light on the pharmacokinetic behavior of clopidogrel in the context of the Moroccan male population, offering valuable insights into the comparability of formulations.