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A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions

NCT00865852 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is compare the relative bioavailability of 750 mg Metformin Hydrochloride Extended Release Tablets by Purepac Pharmaceutical Co with that of 750 mg GLUCOPHAGE® XR Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 750 mg) in healthy adult volunteers under non-fasting conditions

Conditions

  • Healthy

Interventions

DRUG

Metformin HCl 750 mg Extender Release tablets, single dose

A: Experimental Subjects received Purepac formulated products under non-fasting conditions

DRUG

GLUCOPHAGE® XR 750 mg tablets, single dose

B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm.D, · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865852 on ClinicalTrials.gov