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NCT00468897

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

Completed Phase 1 Last updated 7 August 2017
What this trial tests

Phase 1 trial testing RSG XR in Alzheimer's Disease in 50 participants. Completed in 2 May 2007.

Timeline
21 March 2007
Primary endpoint
2 May 2007
2 May 2007

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment50
Start date21 March 2007
Primary completion2 May 2007
Estimated completion2 May 2007
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. PPARγ/PGC1α signaling as a potential therapeutic target for mitochondrial biogenesis in neurodegenerative disorders.
    Jamwal S, Blackburn JK, Elsworth JD. · · 2021 · cited 189× · PMID 33039420 · DOI 10.1016/j.pharmthera.2020.107705
  2. Sulfur-containing therapeutics in the treatment of Alzheimer's disease.
    Zhu H, Dronamraju V, Xie W, More SS. · · 2021 · cited 25× · PMID 33613018 · DOI 10.1007/s00044-020-02687-1

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Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00468897.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing