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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.

NCT00650169 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 47 participants
Start Date 2004-12
Est. Completion 2005-01
Phase Phase 1
Mylan Pharmaceuticals

146 total trials

What the finished NCT00650169 record still lists

NCT00650169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 2 interventions - of which Clopidogrel Bisulfate Tablets 75 mg is the first listed.

NCT00650169 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00650169's enrollment target sits among peer trials

47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00650169, the US trial registry maintained by the National Library of Medicine. NCT00650169 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.