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Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00919607
First received: June 11, 2009
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: quetiapine fumarate extended-release
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • single dose PK parameters(300mg) [ Time Frame: Day1 to 48 hour after Day 5 ] [ Designated as safety issue: No ]
  • Steady-state multiple doses PK parameters [ Time Frame: Day 1 to 48 hours after Day7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of AEs [ Time Frame: sign ICF to Day 9 ] [ Designated as safety issue: Yes ]
  • Clinical significant change in Lab test [ Time Frame: baseline up to Day 9 ] [ Designated as safety issue: Yes ]
  • Clinical significant change in vital signs [ Time Frame: baseline up to Day 9 ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919607

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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00919607     History of Changes
Other Study ID Numbers: D1444C00007
Study First Received: June 11, 2009
Last Updated: March 25, 2010
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013