Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison
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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jul 2008
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 16, 2009
July 1, 2009
1 month
June 19, 2008
July 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Area under the VAS-time curve
Calculated daily from the 13 assessments for 5 days
Secondary Outcomes (1)
Pharmacodynamic relationship between maximum VAS and PK concentration
On last day of period (Day 5)
Study Arms (2)
1
EXPERIMENTALQuetiapine Fumarate Immediate Release
2
EXPERIMENTALQuetiapine Fumarate Extended Release
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- Weight of at least 50 kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Baltimore, Maryland, United States
Related Publications (1)
Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther. 2009 Mar;31(3):492-502. doi: 10.1016/j.clinthera.2009.03.002.
PMID: 19393840DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine Datto, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 16, 2009
Record last verified: 2009-07