Back to resultsA Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
RSG XR
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimers Disease, healthy volunteers, bioequivalence
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment Arm AB
Treatment Arm BA
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
PK samples
Secondary Outcome Measures
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468897
Brief Title
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 21, 2007 (Actual)
Primary Completion Date
May 2, 2007 (Actual)
Study Completion Date
May 2, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimers Disease, healthy volunteers, bioequivalence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm AB
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm BA
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
RSG XR
Other Intervention Name(s)
BRL-049653
Intervention Description
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.
Primary Outcome Measure Information:
Title
PK samples
Time Frame
at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32
Secondary Outcome Measure Information:
Title
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
Time Frame
Up to 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study To Demonstrate The Bioequivalence Of Rosiglitazone XR (BRL-049653) 8mgs XR Manufactured At Two Different Sites.
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