Quetiapine Fumarate Immediate Release (IR) versus Extended Release (XR) Dose Escalation Comparison
Study identifier:D1443C00033
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Quetiapine Fumarate
Sex
All
Actual Enrollment
63
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
Contacts
Investigators
Principal Investigator
Catherine Datto
AstraZeneca
