Clincosm LogoSign in Get a demo

Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00919607
Collaborator
(none)
31
Enrollment
1
Location
3
Arms
9
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: quetiapine fumarate extended-release
  • Drug: quetiapine fumarate extended-release
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

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

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
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. single dose PK parameters(300mg) [Day1 to 48 hour after Day 5]

    2. Steady-state multiple doses PK parameters [Day 1 to 48 hours after Day7]

    Secondary Outcome Measures

    1. Incidence and severity of AEs [sign ICF to Day 9]

    2. Clinical significant change in Lab test [baseline up to Day 9]

    3. Clinical significant change in vital signs [baseline up to Day 9]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Beijing Beijing China

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00919607
    Other Study ID Numbers:
    • D1444C00007
    First Posted:
    Jun 12, 2009
    Last Update Posted:
    Mar 26, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study
    pharmacokinetics parameters
    Additional relevant MeSH terms:
    Schizophrenia
    Quetiapine Fumarate

    Study Results

    No Results Posted as of Mar 26, 2010