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NCT00702676 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00702676
Other study ID # D1443C00033
Secondary ID
Status Completed
Phase Phase 1
First received June 19, 2008
Last updated July 15, 2009
Start date July 2008
Est. completion date August 2008

Study information
Verified date July 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine Fumarate
Tablet, Oral, once daily
• Quetiapine Fumarate
Tablet, Oral, once daily

Locations
Country Name City State
United States Research Site Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) 1 hour post dose at Day 1 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period No
Primary Area under the VAS-time curve Calculated daily from the 13 assessments for 5 days No
Secondary Pharmacodynamic relationship between maximum VAS and PK concentration On last day of period (Day 5) No
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