CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg +1 moredrug
Likely dose
Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01332071
NCT01332071Phase 1Completed
CompareCT.gov

Assessment of Relative Bioavailability of Avandamet 4 mg + 1000 mg (GSK) in the Form of Film Coated Tablets Versus Avandamet 2 mg + 500 mg (GSK) in the Form of Film Coated Tablets, in Healthy Volunteers After Feeding Standardized, Using Liquid Chromatography.

GlaxoSmithKline·interventional·Posted Apr 8, 2011·Updated Jul 12, 2017

In Brief

A Phase 1 clinical trial evaluating Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg and Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg for Diabetes Mellitus, Type 2. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBrazil
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2011
Enrollment StartNov 24, 2009
Primary CompletionDec 6, 2009
TodayJul 2, 2026
Enrollment to primary: 12 daysPosted 15.2 years ago

Interventions

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

Avandamet reference product

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

Avandamet test product