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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00468897
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 in fasting healthy volunteers

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: RSG XR Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Actual Study Start Date : March 21, 2007
Primary Completion Date : May 2, 2007
Study Completion Date : May 2, 2007


Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment Arm AB
A will be a single tablet RSG XR 8 milligram (mg) manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm AB subject will receive A regimen in Period 1 and B regimen in Period 2.There will be wash-out period of 5 days between doses.
Drug: RSG XR
RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
Other Name: BRL-049653
Experimental: Treatment Arm BA
A will be a single tablet RSG XR 8 mg manufactured in Harlow administered in the fasted state and B will be a single tablet RSG XR 8 mg manufactured in Crawley administered in the fasted state. In Arm BA subject will receive B regimen in Period 1 and A regimen in Period 2. There will be wash-out period of 5 days between doses.
Drug: RSG XR
RSG XR tablets 8 mg enteric-coated tablet formulation consisting of 3mg fast release plus 5mg slow release. Subject will receive one 8mg of RSG XR on each dosing day. The subject will receive a single oral dose of regiment A or B with 240 milliliter (mL) of water.
Other Name: BRL-049653


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements. [ Time Frame: Up to 32 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468897


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00468897     History of Changes
Other Study ID Numbers: AXR107453
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Alzheimers Disease
healthy volunteers
bioequivalence

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs