A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.

• Status: Completed
• Trial end date: 2007-05-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Rosiglitazone

Criteria

Inclusion Criteria:

• Healthy male or female aged 18-55 years.

• BMI between 19 - 30 kg/m2

Exclusion criteria:

• Liver function tests above the upper limit

• Excessive alcohol consumption history

• History of Cigarette smoking

• Positive HIV, Hep B or C test

• Positive pregnancy test

• History of heparin sensitivity

• History of glucose intolerance