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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468897
• Other study ID #: AXR107453
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2007
• Last updated: August 3, 2017
• Start date: March 21, 2007
• Est. completion date: May 2, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2, 2007
• Est. primary completion date: May 2, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK samples		at Pre-dose,0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32
Secondary	Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements.		Up to 32

External Links

•   Results for study AXR107453 can be found on the GSK Clinical Study Register.