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Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects

2014-08-27 03:13:28 | BioPortfolio

Summary

The objectives of the study are to:

- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects

- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

Description

The total study duration per subject is 4 - 6 weeks broken down as follows:

- Screening: 2 to 21 days before the first dosing

- Period 1, 2 and 3: 4 days including 1 treatment day each

- Washout between periods: at least 7 days between 2 administrations

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Clopidogrel

Location

Sanofi-Aventis Administrative Office
Paris
France

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:28-0400

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