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

NCT00865436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Alpharma 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 administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg

A: Experimental Subjects received Alpharma formulated products under fasting conditions

DRUG

CLUCOVANCE® 5 mg/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
2004-04-30
Primary Completion
2004-04-30
Completion
2004-04-30

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 NCT00865436 on ClinicalTrials.gov