Comparative Bioequivalence Study of 2 Clopidogrel 75-mg Tablet Formulations in Moroccan Volunteers.
Clin Pharmacol Drug Dev
; 13(9): 1044-1050, 2024 Sep.
Article
em En
| MEDLINE
| ID: mdl-38924629
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 (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.
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Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Comprimidos
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Inibidores da Agregação Plaquetária
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Equivalência Terapêutica
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Estudos Cross-Over
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Área Sob a Curva
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Clopidogrel
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article