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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Quetiapine Fumarate

• Registration Number: NCT00702676
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Study Start: 2008-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-15
• Last Update Posted: 2009-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Weight of at least 50 kg

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Quetiapine Fumarate	Quetiapine Fumarate Immediate Release
2	Quetiapine Fumarate	Quetiapine Fumarate Extended Release

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacodynamic relationship between maximum VAS and PK concentration	On last day of period (Day 5)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States