Evaluate the Pharmacokinetics of Quetiapine Fumarate in C... | NCT00919607

Studies
Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

NCT00919607

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 26, 2010Estimated

Enrollment

31Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

quetiapine fumarate extended-release
quetiapine fumarate extended-release

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 11, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2010

Last Update Posted Date

Mar 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	quetiapine fumarate extended-release 300mg,administered once-daily Day1~5	Drug: quetiapine fumarate extended-release
2	Experimental	quetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily	Drug: quetiapine fumarate extended-release
3	Experimental	quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily	Drug: quetiapine fumarate extended-release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
quetiapine fumarate extended-release	Drug	200mg,oral,single dose	3

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tianmei Si	Peking University Institute of Mental Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided