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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Quetiapine Fumarate (Drug); Quetiapine Fumarate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Datto, MD, Study Director, Affiliation: AstraZeneca


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Visual Analog Scale (VAS) 1 hour post dose at Day 1

Area under the VAS-time curve

Secondary outcome: Pharmacodynamic relationship between maximum VAS and PK concentration


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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

Locations and Contacts

Research Site, Baltimore, Maryland, United States
Additional Information

Starting date: July 2008
Last updated: July 15, 2009

Page last updated: August 23, 2015

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