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NCT00649350 · ClinicalTrials.gov registry record · Phase 1

Food Study Metformin Hydrochloride ER Tablets 750 mg and Glucophage XR 750 mg

A Phase 1 study, sponsored by Mylan Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00649350 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 28 participants.

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The verdict

NCT00649350, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under fed conditions.

Interventions

  • DRUG Metformin Hydrochloride ER Tablets 750 mg
  • DRUG Glucophage XR 750 mg

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2003-12
Est. Completion 2003-12
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00649350

The ClinicalTrials.gov registry entry for NCT00649350 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 Metformin Hydrochloride ER Tablets 750 mg is the first listed.

NCT00649350 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00649350 about?

NCT00649350 is a clinical study titled "Food Study Metformin Hydrochloride ER Tablets 750 mg and Glucophage XR 750 mg". The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under fed conditions.

What is the current status of trial NCT00649350?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2003-12. Estimated completion is 2003-12.

What interventions are being tested in trial NCT00649350?

The interventions under investigation include: Metformin Hydrochloride ER Tablets 750 mg (DRUG), Glucophage XR 750 mg (DRUG).

Who is sponsoring clinical trial NCT00649350?

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

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.