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

Aimen El OrcheChoukri El KhabbazAmine CheikhHouda BouchafraSamira JawhariFaouzi My El AbbesYahya Cherrah
Published in: Clinical pharmacology in drug development (2024)
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 (C max ), area under the concentration-time curve from 0 to the last measurable time (AUC 0-t ), and area under the concentration-time curve extrapolated to infinity (AUC 0-∞ ). The results revealed that the geometric mean ratios of C max , AUC 0-t , and AUC 0-∞ 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.
Keyphrases
  • acute coronary syndrome
  • drug delivery
  • percutaneous coronary intervention
  • antiplatelet therapy
  • emergency department
  • coronary artery disease
  • single cell
  • atrial fibrillation