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Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects

2014-08-27 03:13:40 | BioPortfolio

Summary

Primary Objective:

- Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects

Secondary Objectives:

- Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)

- Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen

Description

The total study duration per subject is 10-12 weeks broken down as follows:

- Screening: 2 to 40 days before the first dosing

- Period 1: 7 days including 5 days treatment

- Washout: At least 14 days after the last dosing

- Period 2: 7 days including 5 days treatment

- End of study: 7 to 10 days after the last dosing

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Conditions

Healthy

Intervention

CLOPIDOGREL, placebo

Location

Sanofi-Aventis Administrative Office
Berlin
Germany

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:40-0400

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