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
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2007
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2007
CompletedFirst Submitted
Initial submission to the registry
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2007
CompletedFirst Posted
Study publicly available on registry
May 3, 2007
CompletedAugust 7, 2017
August 1, 2017
1 month
May 1, 2007
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK samples
at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32
Secondary Outcomes (1)
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.
Up to 32
Study Arms (2)
Treatment Arm AB
EXPERIMENTALA 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.
Treatment Arm BA
EXPERIMENTALA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy male or female aged 18-55 years.
- BMI between 19 - 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2007
First Posted
May 3, 2007
Study Start
March 21, 2007
Primary Completion
May 2, 2007
Study Completion
May 2, 2007
Last Updated
August 7, 2017
Record last verified: 2017-08