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

July 15, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Quetiapine Fumarate Immediate Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Names:
  • Seroquel XR
Experimental: 2
Quetiapine Fumarate Extended Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Names:
  • Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 hour after dose administration at the first dosing day (i.e. Day 1) of each period
Area under the VAS-time curve
Time Frame: Calculated daily from the 13 assessments for 5 days
Calculated daily from the 13 assessments for 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic relationship between maximum VAS and PK concentration
Time Frame: On last day of period (Day 5)
On last day of period (Day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2009

Last Update Submitted That Met QC Criteria

July 15, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443C00033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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