Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

Phase 1 Completed 63 enrolled AstraZeneca

RandomizedCrossoverDouble-blindTreatment

Summary

This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.

Timeline

Start: 2008-07
Primary completion: 2008-08
Completion: 2008-08

Publications

Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther. 2009 Mar;31(3):492-502. doi: 10.1016/j.clinthera.2009.03.002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quetiapine	Small molecule	300 mg	Oral

Indications

No indication recorded.