An open-label, randomised, 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.

Trial Profile

An open-label, randomised, 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.

Completed
Phase of Trial: Phase I

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Rosiglitazone (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 15 Oct 2008 Actual start date changed from Feb 2007 to Mar 2007 as reported by Clinicaltrials.gov.
    • 28 Jan 2008 Status changed from recruiting to completed from ClinicalTrials.gov update.
    • 10 Jul 2007 New trial record.
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