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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00468897
First received: May 1, 2007
Last updated: August 3, 2017
Last verified: August 2017
May 1, 2007
August 3, 2017
March 21, 2007
May 2, 2007   (Final data collection date for primary outcome measure)
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. [ Time Frame: Up to 32 ]
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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
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 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.
    Intervention: Drug: RSG XR
  • 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.
    Intervention: Drug: RSG XR
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 2, 2007
May 2, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00468897
AXR107453
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

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