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Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg

NCT00649454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Glipizide and Metformin HCl Tablets 5 mg/500 mg

5/500mg, single dose fasting

DRUG

Metaglip® Tablets 5 mg/500 mg

5/500mg, single dose fasting

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2005-06-30
Completion
2005-06-30

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 NCT00649454 on ClinicalTrials.gov