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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.
Information provided by:
GlaxoSmithKline Identifier:
First received: May 1, 2007
Last updated: October 15, 2008
Last verified: October 2008
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

Condition Intervention Phase
Alzheimer's Disease Drug: BRL-049653 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK samples [ Time Frame: at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32 ]

Secondary Outcome Measures:
  • Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.

Estimated Enrollment: 50
Study Start Date: March 2007
Study Completion Date: May 2007

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00468897

GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00468897     History of Changes
Other Study ID Numbers: AXR107453
Study First Received: May 1, 2007
Last Updated: October 15, 2008

Keywords provided by GlaxoSmithKline:
Alzheimers Disease
healthy volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on July 26, 2017