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NCT00864669 · ClinicalTrials.gov registry record · Phase 1

A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Non-fasting Conditions

A Phase 1 study, sponsored by Actavis.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00864669: Completed Phase 1 study, sponsored by Actavis.

NCT00864669 is a Phase 1 study that has completed, run by Actavis. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00864669, 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 non-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
Actavis

79 total trials

What the finished NCT00864669 record still lists

NCT00864669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

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

NCT00864669 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00864669 about?

NCT00864669 is a clinical study titled "A Relative Bioavailability Study of Metformin HCl 500 mg ER Tablets Under Non-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 NCT00864669?

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 NCT00864669?

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 NCT00864669?

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

How this trial's enrollment target compares

Where NCT00864669's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00864669, the US trial registry maintained by the National Library of Medicine. NCT00864669 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.