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Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT00919607
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 26, 2010
Sponsor:
Information provided by:
AstraZeneca

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
Schizophrenia Drug: quetiapine fumarate extended-release Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: 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 Name: SEROQUEL XR
Drug: quetiapine fumarate extended-release
300mg,oral,single dose
Other Name: SEROQUEL XR



Primary Outcome Measures :
  1. single dose PK parameters(300mg) [ Time Frame: Day1 to 48 hour after Day 5 ]
  2. Steady-state multiple doses PK parameters [ Time Frame: Day 1 to 48 hours after Day7 ]

Secondary Outcome Measures :
  1. Incidence and severity of AEs [ Time Frame: sign ICF to Day 9 ]
  2. Clinical significant change in Lab test [ Time Frame: baseline up to Day 9 ]
  3. Clinical significant change in vital signs [ Time Frame: baseline up to Day 9 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919607


Locations
China, Beijing
Research Site
Beijing, Beijing, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Tianmei Si Peking University Institute of Mental Health

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00919607     History of Changes
Other Study ID Numbers: D1444C00007
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010

Keywords provided by AstraZeneca:
quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study
pharmacokinetics parameters

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs