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

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Article Abstract

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), area under the concentration-time curve from 0 to the last measurable time (AUC), and area under the concentration-time curve extrapolated to infinity (AUC). The results revealed that the geometric mean ratios of C, AUC, and AUC 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.

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http://dx.doi.org/10.1002/cpdd.1442DOI Listing

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