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.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- Healthy male or female aged 18-55 years.
- BMI between 19 - 30 kg/m2
- Liver function tests above the upper limit
- Excessive alcohol consumption history
Inclusion and exclusion 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
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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
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Additional information
Results for study AXR107453 can be found on the GSK Clinical Study Register.
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