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NCT00650169 · ClinicalTrials.gov registry record · Phase 1
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT00650169 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 47 participants.
The verdict
NCT00650169, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.
Interventions
- DRUG Clopidogrel Bisulfate Tablets 75 mg
- DRUG Plavix® Tablets 75 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650169
The ClinicalTrials.gov registry entry for NCT00650169 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel Bisulfate Tablets 75 mg is the first listed.
NCT00650169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650169 about?
NCT00650169 is a clinical study titled "Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg". The objective of this study was to investigate the bioequivalence of Mylan's clopidogrel bisulfate 75 mg tablets to Bristol-Myers Squibb/Sanofi's Plavix® 75 mg tablets following a single, oral 75 mg (1 x 75 mg) dose administered under fed conditions.
What is the current status of trial NCT00650169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2004-12. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00650169?
The interventions under investigation include: Clopidogrel Bisulfate Tablets 75 mg (DRUG), Plavix® Tablets 75 mg (DRUG).
Who is sponsoring clinical trial NCT00650169?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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