NCT02502812

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Clop F1	A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
DRUG	Clop F2	A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
DRUG	Innovator	A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.

Timeline

• Start date: 2015-09-04
• Primary completion: 2015-09-24
• Completion: 2015-09-24
• First posted: 2015-07-20
• Last updated: 2017-05-08

Locations

1 site across 1 country: India