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Trial record 88 of 450 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702676
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : July 16, 2009
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Quetiapine Fumarate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Quetiapine Fumarate Immediate Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Name: Seroquel IR

Experimental: 2
Quetiapine Fumarate Extended Release
Drug: Quetiapine Fumarate
Tablet, Oral, once daily
Other Name: Seroquel XR

Primary Outcome Measures :
  1. 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 ]
  2. Area under the VAS-time curve [ Time Frame: Calculated daily from the 13 assessments for 5 days ]

Secondary Outcome Measures :
  1. Pharmacodynamic relationship between maximum VAS and PK concentration [ Time Frame: On last day of period (Day 5) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00702676

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United States, Maryland
Research Site
Baltimore, Maryland, United States
Sponsors and Collaborators
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Study Director: Catherine Datto, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hans A Eriksson, MD, Medical Science Director, AstraZeneca Pharmaceuticals Identifier: NCT00702676     History of Changes
Other Study ID Numbers: D1443C00033
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 2009
Keywords provided by AstraZeneca:
Healthy Volunteers
Additional relevant MeSH terms:
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Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs