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Avandamet Bioequivalence Study Brazil - Fed Administration

NCT01332071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-07-12

Study results available
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Summary

The study is prospective, open-label, randomized, crossover, with 02 treatments, 02 sequences, and 02 periods. The volunteers received, in each period, the reference or the test formulation after standardized meals.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg

Avandamet reference product

DRUG

Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg

Avandamet test product

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-24
Primary Completion
2009-12-06
Completion
2009-12-06

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

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 NCT01332071 on ClinicalTrials.gov