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Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting

NCT00836472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-19

Study results available
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Summary

The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Glyburide/Metformin 5 mg/500 mg Tablets

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

DRUG

Glucovance® 5 mg/500 mg Tablets

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

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Richard Larouche, M.D. · Anapharm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2003-04-30
Completion
2003-04-30

Countries

  • Canada

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 NCT00836472 on ClinicalTrials.gov