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

Study identifier:D1443C00033

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) with Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Quetiapine Fumarate

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Jul 2008

Primary Completion Date: 01 Aug 2008

Study Completion Date: 01 Aug 2008

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Baltimore, MD, United States

Arms	Assigned Interventions
Experimental: 1 Quetiapine Fumarate Immediate Release	Drug: Quetiapine Fumarate Tablet, Oral, once daily Other Name: Seroquel IR
Experimental: 2 Quetiapine Fumarate Extended Release	Drug: Quetiapine Fumarate Tablet, Oral, once daily Other Name: Seroquel XR

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1759&filename=CSR-D1443C00033.pdf
Download
CSR-D1443C00033.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Catherine Datto

AstraZeneca