A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
The present pharmacokinetic study is designed to compare bioavailability and assess bioequivalence of two Rosiglitazone XR formulations produced at two different sites.Both formulations will be tested in fasting healthy volunteers
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of a Tablet Formulation of Rosiglitazone XR (BRL-049653) 8mg Manufactured at Two Different Sites in Healthy Volunteers in Fasting Conditions|
- PK samples [ Time Frame: at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32 ]
- Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
|Study Start Date:||March 2007|
|Study Completion Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468897
|GSK Investigational Site|
|Neuss, Nordrhein-Westfalen, Germany, 41460|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|