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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00702676 |
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 | Intervention | Phase |
---|---|---|
Healthy Volunteers |
Drug: Quetiapine Fumarate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment |
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 |
Enrollment: | 63 |
Study Start Date: | July 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Quetiapine Fumarate Immediate Release
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Drug: Quetiapine Fumarate
Tablet, Oral, once daily
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2: Experimental
Quetiapine Fumarate Extended Release
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Drug: Quetiapine Fumarate
Tablet, Oral, once daily
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca Pharmaceuticals ( Hans A Eriksson, MD, Medical Science Director ) |
Study ID Numbers: | D1443C00033 |
Study First Received: | June 19, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00702676 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Healthy Volunteers |
Quetiapine Tranquilizing Agents Psychotropic Drugs |
Central Nervous System Depressants Healthy Antipsychotic Agents |
Quetiapine Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |