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

This study has been completed.

First Received: May 1, 2007 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00468897

Purpose

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 I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468897

Locations

Germany, Nordrhein-Westfalen
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:

Alzheimers Disease
bioequivalence
healthy volunteers

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 06, 2009