Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

NCT ID: NCT00919607

Last Updated: 2010-03-26

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-03-31

Brief Summary

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The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

quetiapine fumarate extended-release 300mg,administered once-daily Day1\~5

Group Type ACTIVE_COMPARATOR

quetiapine fumarate extended-release

Intervention Type DRUG

300mg,oral,single dose

2

quetiapine fumarate extended-release 300mg/Day1,600mg/Day2\~6,administered once-daily

Group Type EXPERIMENTAL

quetiapine fumarate extended-release

Intervention Type DRUG

300mg,oral,single dose

3

quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3\~7,administered once-daily

Group Type EXPERIMENTAL

quetiapine fumarate extended-release

Intervention Type DRUG

200mg,oral,single dose

quetiapine fumarate extended-release

Intervention Type DRUG

300mg,oral,single dose

Interventions

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quetiapine fumarate extended-release

200mg,oral,single dose

Intervention Type DRUG

quetiapine fumarate extended-release

300mg,oral,single dose

Intervention Type DRUG

Other Intervention Names

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SEROQUEL XR SEROQUEL XR

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 through 60 years inclusive
* Schizophrenia diagnosis
* Body Mass Index (BMI) 20-27 kg/m2 (inclusive)
* Provision of written informed consent before initiation of any study

Exclusion Criteria

* AIDS \& hepatitis B
* History of seizure disorder
* History of episodic,idiopathic orthostatic hypotension
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Tianmei Si

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Mental Health

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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D1444C00007

Identifier Type: -

Identifier Source: org_study_id

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