Last updated: 11/04/2018 05:23:55

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

GSK study ID
AXR107453
See study documents
Clinicaltrials.gov ID
NCT00468897
EudraCT ID
2006-006372-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

PK samples

Timeframe: at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32

Secondary outcomes:

Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.

Timeframe: Up to 32

Interventions:
  • Drug: RSG XR
    • Enrollment:
    50
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Alzheimer's Disease
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    March 2007 to May 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy male or female aged 18-55 years.
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Neuss, Nordrhein-Westfalen, Germany, 41460
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-02-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study AXR107453 can be found on the GSK Clinical Study Register.
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    Access to clinical trial data by researchers
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