Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00702676

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: Quetiapine Fumarate	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
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

Resource links provided by NLM:

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Visual Analog Scale (VAS) 1 hour post dose at Day 1 [ Time Frame: 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period ] [ Designated as safety issue: No ]
Area under the VAS-time curve [ Time Frame: Calculated daily from the 13 assessments for 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamic relationship between maximum VAS and PK concentration [ Time Frame: On last day of period (Day 5) ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	July 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Quetiapine Fumarate Immediate Release	Drug: Quetiapine Fumarate Tablet, Oral, once daily
2: Experimental Quetiapine Fumarate Extended Release	Drug: Quetiapine Fumarate Tablet, Oral, once daily

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Weight of at least 50 kg

Exclusion Criteria:

A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Positive test results for alcohol or drugs of abuse
Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702676

Locations

United States, Maryland
Research Site
Baltimore, Maryland, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Datto, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	AstraZeneca Pharmaceuticals ( Hans A Eriksson, MD, Medical Science Director )
Study ID Numbers:	D1443C00033
Study First Received:	June 19, 2008
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00702676 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by AstraZeneca:

Healthy Volunteers

Additional relevant MeSH terms:

Quetiapine
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010