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NCT00865839 · ClinicalTrials.gov registry record · Phase 1

A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Fasting Conditions

A Phase 1 study, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00865839 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 32 participants.

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The verdict

NCT00865839, a Phase 1 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

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

Interventions

  • DRUG Metformin HCl 500 mg tablets, single dose
  • DRUG CLUCOPHAGE® XR 500 mg tablets, single dose

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2002-03
Est. Completion 2002-03
Phase Phase 1

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT00865839

The ClinicalTrials.gov registry entry for NCT00865839 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Metformin HCl 500 mg tablets, single dose is the first listed.

NCT00865839 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00865839 about?

NCT00865839 is a clinical study titled "A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Fasting Conditions". The purpose of this study is to compare the relative bioavailability of 500 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co. with that of 500 mg CLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 500 mg extended-release tablet) i...

What is the current status of trial NCT00865839?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2002-03. Estimated completion is 2002-03.

What interventions are being tested in trial NCT00865839?

The interventions under investigation include: Metformin HCl 500 mg tablets, single dose (DRUG), CLUCOPHAGE® XR 500 mg tablets, single dose (DRUG).

Who is sponsoring clinical trial NCT00865839?

This trial is sponsored by Actavis, which has 79 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.