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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

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.

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

Eligibility

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

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

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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