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Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

NCT01129271 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-12-15

No results posted yet for this study

Summary

Primary objective:

* Investigate the potential food effect on Adenosine diphosphate(ADP)-induced platelet aggregation after 5-day repeated doses of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) in healthy subjects

Secondary objectives are to investigate the potential food effect on:

* ADP-induced platelet aggregation after 300 mg loading dose of clopidogrel
* Pharmacokinetic profiles of clopidogrel and its active metabolite after 5-day repeated doses of clopidogrel

Conditions

  • Healthy

Interventions

DRUG

clopidogrel

Pharmaceutical form: tablet Route of administration: oral

DRUG

Matching placebo

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • International Clinical Development Study Director · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01129271 on ClinicalTrials.gov