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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: RSG XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468897

AXR107453

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Treatment Arm AB

Experimental group

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.

Treatment:

Drug: RSG XR

Treatment Arm BA

Experimental group

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.

Treatment:

Drug: RSG XR