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Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg

NCT00648492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-04-24

No results posted yet for this study

Summary

The objective of this study is to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Metformin Hydrochloride ER Tablets 500 mg

500mg, single dose fed

DRUG

Glucophage® XR 500 mg

500mg, single dose fed

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
2002-10-31
Primary Completion
2002-11-30
Completion
2002-11-30

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 NCT00648492 on ClinicalTrials.gov