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NCT00648947 · ClinicalTrials.gov registry record · Phase 1

Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg

A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
1
Study location

NCT00648947 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 46 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00648947, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target
1
Study location

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 fasting conditions.

Conditions Studied

Interventions

  • DRUG Clopidogrel Bisulfate Tablets 75 mg
  • DRUG Plavix® Tablets 75 mg

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2004-12
Est. Completion 2004-12
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648947

The ClinicalTrials.gov registry entry for NCT00648947 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Clopidogrel Bisulfate Tablets 75 mg is the first listed.

NCT00648947 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.

Frequently Asked Questions

What is clinical trial NCT00648947 about?

NCT00648947 is a clinical study titled "Fasting 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 fasting conditions.

What is the current status of trial NCT00648947?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2004-12. Estimated completion is 2004-12.

What conditions does trial NCT00648947 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00648947?

The interventions under investigation include: Clopidogrel Bisulfate Tablets 75 mg (DRUG), Plavix® Tablets 75 mg (DRUG).

Who is sponsoring clinical trial NCT00648947?

This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00648947 being conducted?

This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.