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

NCT00865839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-08-17

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Metformin HCl 500 mg tablets, single dose

A: Experimental Subjects received Purepac formulated products under fasting conditions

DRUG

CLUCOPHAGE® XR 500 mg tablets, single dose

B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under 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
2002-03-31
Primary Completion
2002-03-31
Completion
2002-03-31

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 NCT00865839 on ClinicalTrials.gov