Alzheimer's Disease Clinical Trial
Official title:
A Study to Evaluate the Effect of Extended Release Rosiglitazone (RSG XR) on Cardiac Conduction as Compared to Placebo and a Single Oral Dose of Moxifloxacin
This study is a randomised double blind, parallel group, and will evaluate the effects of repeat oral doses of RSG- XR for 21 days on the QTc interval compared to placebo in a population of healthy adult males and females.
An extended release (XR) formulation of rosiglitazone maleate (RSG), a new formulation of
rosiglitazone, is being investigated as a treatment for patients with mild to moderate
Alzheimer's disease (AD).
This study is a randomised double blind, parallel group, and will evaluate the effects of
repeat oral doses of RSG- XR for 21 days (due to the long half-life of the main metabolite
M10) on the QTc interval compared to placebo in a population of healthy adult males and
females between 18 and 45 years of age. Moxifloxacin, a drug with well-quantified QTc
prolongation, will be included as a positive control in order to validate the ability of the
study to detect small changes in QTc.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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