Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
Status:
Completed
Trial end date:
2015-09-24
Target enrollment:
Participant gender:
Summary
Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate
(ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way
cross over, six sequence study to investigate the relative bioavailability of two 75
milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1
[Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference
product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be
randomized, such that approximately 14 evaluable subjects complete the study. Total duration
in the study for each subject will be approximately 8 weeks from screening to the follow-up
visit.