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NCT00648492 · ClinicalTrials.gov registry record · Phase 1

Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg

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

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT00648492 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 18 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00648492, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.

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

Study Summary

The objective of this study is 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 fed conditions.

Conditions Studied

Interventions

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

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2002-10
Est. Completion 2002-11
Phase Phase 1

Sponsor

Mylan Pharmaceuticals

146 total trials

What the Registry Record Tells You About NCT00648492

The ClinicalTrials.gov registry entry for NCT00648492 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 (97% 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.

NCT00648492 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.

Frequently Asked Questions

What is clinical trial NCT00648492 about?

NCT00648492 is a clinical study titled "Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg". The objective of this study is 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 fed conditions.

What is the current status of trial NCT00648492?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2002-10. Estimated completion is 2002-11.

What conditions does trial NCT00648492 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00648492?

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

Who is sponsoring clinical trial NCT00648492?

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

Where is trial NCT00648492 being conducted?

This trial has 1 study location across North Dakota. 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.