Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

March 25, 2010 updated by: AstraZeneca
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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
quetiapine fumarate extended-release 300mg,administered once-daily Day1~5
Drug: quetiapine fumarate extended-release
200mg,oral,single dose
Other Names:
  • SEROQUEL XR
Drug: quetiapine fumarate extended-release
300mg,oral,single dose
Other Names:
  • SEROQUEL XR
Experimental: 2
quetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily
Drug: quetiapine fumarate extended-release
200mg,oral,single dose
Other Names:
  • SEROQUEL XR
Drug: quetiapine fumarate extended-release
300mg,oral,single dose
Other Names:
  • SEROQUEL XR
Experimental: 3
quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily
Drug: quetiapine fumarate extended-release
200mg,oral,single dose
Other Names:
  • SEROQUEL XR
Drug: quetiapine fumarate extended-release
300mg,oral,single dose
Other Names:
  • SEROQUEL XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
single dose PK parameters(300mg)
Time Frame: Day1 to 48 hour after Day 5
Day1 to 48 hour after Day 5
Steady-state multiple doses PK parameters
Time Frame: Day 1 to 48 hours after Day7
Day 1 to 48 hours after Day7

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of AEs
Time Frame: sign ICF to Day 9
sign ICF to Day 9
Clinical significant change in Lab test
Time Frame: baseline up to Day 9
baseline up to Day 9
Clinical significant change in vital signs
Time Frame: baseline up to Day 9
baseline up to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Tianmei Si, Peking University Institute of Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2010

Last Update Submitted That Met QC Criteria

March 25, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1444C00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on quetiapine fumarate extended-release

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe