Comparative Bioavailability Study of Two Oral Formulations of Clopidogrel
Status:
Terminated
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
Background: Clopidogrel, a potent inhibitor of adenosine diphosphate-induced platelet
activation, is widely used to prevent and reduce the risk of thrombotic events. Objective:
the aim of the present study is to evaluate the bioequivalence of two oral formulations of 75
mg clopidogrel tablets. Method: The study is an open, randomized, single-dose, two-period
crossover trial conducted on 32 healthy Mexican volunteers in a fasted state. A single oral
dose of the test or reference drug will be followed by a 7 day washout period, after which
subjects will receive the alternative formulation. Blood samples were collected up to 24 h
after dosing. In order to determine bioequivalence, the plasma concentrations of clopidogrel
carboxylic acid metabolite was determined using high-performance liquid chromatography-tandem
mass spectrometry area under the plasma concentration time curve from zero to the last
quantifiable level (AUC0-t), area under the plasma concentration time curve extrapolated to
infinity (AUC0-∞), maximum plasma concentration (Cmax), the plasma elimination half-life
(Tmax) and plasma half-life (T1/2) were calculated for both formulations.