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Interaction Study of Clopidogrel 600/150 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

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

Summary

Primary objective:

- Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects

Secondary Objective:

- Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

Description

The total study duration per subjects is 8 - 9 weeks broken down as follows:

- Screening: 2 to 21 days before the first dosing (clopidogrel or omeprazole)

- Period clopidogrel/placebo: 7 days including 5 days treatment

- Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment

- Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment

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

Study Design

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

Conditions

Healthy

Intervention

Clopidogrel, Placebo, Omeprazole

Location

Sanofi-Aventis Administrative Office
Bridgewater
New Jersey
United States
08807

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

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

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