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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Quetiapine Fumarate Immediate Release

Group Type EXPERIMENTAL

Quetiapine Fumarate

Intervention Type DRUG

Tablet, Oral, once daily

2

Quetiapine Fumarate Extended Release

Group Type EXPERIMENTAL

Quetiapine Fumarate

Intervention Type DRUG

Tablet, Oral, once daily

Interventions

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Quetiapine Fumarate

Tablet, Oral, once daily

Intervention Type DRUG

Quetiapine Fumarate

Tablet, Oral, once daily

Intervention Type DRUG

Other Intervention Names

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Seroquel IR Seroquel XR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes