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NCT00650234 · ClinicalTrials.gov registry record · Phase 1

Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg

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

Completed
Registry status
Phase 1
Development phase
47
Enrollment target
1
Study location

NCT00650234 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 47 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

NCT00650234, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

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

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 500 mg (1 x 500 mg) dose administered under fasting conditions.

Conditions Studied

Healthy

Interventions

  • DRUG Metformin Hydrochloride ER Tablets 500 mg
  • DRUG Glucophage® XR Tablets 500 mg

Study Locations (1)

West Virginia

  • Kendle International Inc. - Morgantown

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2004-02
Est. Completion 2004-03
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

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What the Registry Record Tells You About NCT00650234

The ClinicalTrials.gov registry entry for NCT00650234 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, 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 Metformin Hydrochloride ER Tablets 500 mg is the first listed.

NCT00650234 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.

Frequently Asked Questions

What is clinical trial NCT00650234 about?

NCT00650234 is a clinical study titled "Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 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 500 mg (1 x 500 mg) dose administered under fasting conditions.

What is the current status of trial NCT00650234?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2004-02. Estimated completion is 2004-03.

What conditions does trial NCT00650234 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00650234?

The interventions under investigation include: Metformin Hydrochloride ER Tablets 500 mg (DRUG), Glucophage® XR Tablets 500 mg (DRUG).

Who is sponsoring clinical trial NCT00650234?

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

Where is trial NCT00650234 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.