Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Quetiapine Fumarate (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Catherine Datto, MD, Study Director, Affiliation: AstraZeneca
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Primary outcome: 100 mm visual analog scale with range from Alert - Drowsy; Difference between formulations during dose escalationArea 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
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Baltimore, Maryland, United States; Not yet recruiting
Additional Information
Starting date: July 2008
Ending date: August 2008
Last updated: June 19, 2008
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