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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00468897 |
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 |
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Alzheimer's Disease |
Drug: BRL-049653 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Bio-equivalence Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | March 2007 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AXR107453 |
Study First Received: | May 1, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00468897 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
Alzheimers Disease bioequivalence healthy volunteers |
Hypoglycemic Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Rosiglitazone Cognition Disorders Delirium |
Alzheimer Disease Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Pharmacologic Actions |
Delirium, Dementia, Amnestic, Cognitive Disorders Hypoglycemic Agents Mental Disorders Dementia Tauopathies Rosiglitazone |