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Completed

NCT Number: NCT00468897

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RSG XR

Drug

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.

Other names: BRL-049653

Primary outcomes

  1. PK samples

    Time frame: 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.

    Time frame: Up to 32

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 3, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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