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Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects

Cardiovascular Disease Clinical Trial

Official title:
An Open-label, Randomised, Single-dose, Three-way Cross Over, Six Sequence Study to Determine the Relative Bioavailability of Clopidogrel 75mg From Two Tablet Formulations of SB224326 Relative to One 75mg Reference Tablet of Clopidogrel in Healthy Adult Human Subjects Under Fasting Conditions

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02502812
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date September 4, 2015
Completion date September 24, 2015
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