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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00468897
First received: May 1, 2007
Last updated: October 15, 2008
Last verified: October 2008

May 1, 2007
October 15, 2008
March 2007
Not Provided
PK samples [ Time Frame: at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32 ]
Same as current
Complete list of historical versions of study NCT00468897 on ClinicalTrials.gov Archive Site
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements. [ Time Frame: throughout the study ]
Not Provided
Not Provided
 
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: BRL-049653
Other Name: BRL-049653
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2007
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00468897
AXR107453
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP