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NCT00865241 · ClinicalTrials.gov registry record · Phase 1

A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions

A Phase 1 study of Healthy, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT00865241 is a Phase 1 study of Healthy that has completed, run by Actavis. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00865241, a Phase 1 study of Healthy, has completed, sponsored by Actavis.

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

Study Summary

The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult volunteers under fasting conditions.

Conditions Studied

Interventions

  • DRUG Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg
  • DRUG CLUCOVANCE® 5 mg/500 mg Tablets, single dose

Study Locations (1)

North Dakota

  • PRACS Institute, Ltd. - Fargo

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2002-11
Est. Completion 2002-11
Phase Phase 1

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT00865241

The ClinicalTrials.gov registry entry for NCT00865241 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 (94% lower). The listed sponsor is Actavis, which has 79 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 Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg is the first listed.

NCT00865241 reports 1 study location spanning 1 distinct geographic area - top geographies include North Dakota.

Frequently Asked Questions

What is clinical trial NCT00865241 about?

NCT00865241 is a clinical study titled "A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions". The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy ad...

What is the current status of trial NCT00865241?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2002-11. Estimated completion is 2002-11.

What conditions does trial NCT00865241 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00865241?

The interventions under investigation include: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg (DRUG), CLUCOVANCE® 5 mg/500 mg Tablets, single dose (DRUG).

Who is sponsoring clinical trial NCT00865241?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00865241 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.