NCT00919607

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 26, 2010

Status Verified

March 1, 2010

Enrollment Period

9 months

First QC Date

June 11, 2009

Last Update Submit

March 25, 2010

Conditions

Schizophrenia

Keywords

quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Studypharmacokinetics parameters

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • 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

    baseline up to Day 9

Study Arms (3)

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

quetiapine fumarate extended-releaseDRUG

200mg,oral,single dose

Also known as: SEROQUEL XR
3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • AIDS \& hepatitis B
  • History of seizure disorder
  • History of episodic,idiopathic orthostatic hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Tianmei Si

    Peking University Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 26, 2010

Record last verified: 2010-03

Locations

CN(1)