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5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting

NCT00835497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-09-15

Study results available
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Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

5 mg/500 mg Glipizide Metformin Hydrochloride Tablets

1 x 5 mg/500 mg, single-dose fasting

DRUG

5 mg/500 mg METAGLIP™ Tablets

1 x 5 mg/500 mg, single-dose fasting

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    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
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-06-30
Completion
2004-06-30

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 NCT00835497 on ClinicalTrials.gov