Status:
COMPLETED
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 21 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00468897
Start Date
March 21 2007
End Date
May 2 2007
Last Update
August 7 2017
Active Locations (1)
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1
GSK Investigational Site
Neuss, North Rhine-Westphalia, Germany, 41460