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NCT01129271 · ClinicalTrials.gov registry record · Phase 1
Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01129271 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 72 participants.
The verdict
NCT01129271, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
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
Interventions
- DRUG Matching placebo
- DRUG clopidogrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01129271
The ClinicalTrials.gov registry entry for NCT01129271 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT01129271 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01129271 about?
NCT01129271 is a clinical study titled "Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects". 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 o...
What is the current status of trial NCT01129271?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-04. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01129271?
The interventions under investigation include: Matching placebo (DRUG), clopidogrel (DRUG).
Who is sponsoring clinical trial NCT01129271?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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