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

Verified by: AstraZeneca, July 2009
First Received: June 19, 2008 | Last Updated: July 15, 2009 | Phase: Phase 1 | Start Date: July 2008
Overall Status: Completed | Estimated Enrollment: 63
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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...

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Quetiapine Fumarate Immediate Release
  • Experimental: 2
    • Quetiapine Fumarate Extended Release

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: No
  • Area under the VAS-time curve
    • Time Frame: Calculated daily from the 13 assessments for 5 days
      Safety Issue?: No

Secondary Measures

  • Pharmacodynamic relationship between maximum VAS and PK concentration
    • Time Frame: On last day of period (Day 5)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Catherine Datto, MD Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702676

Study ID Number: D1443C00033

ClinicalTrials.gov Identifier: NCT00702676

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00702676