Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919607

Enrollment

Registered

2009-06-12

Start date

2009-06-30

Completion date

2010-03-31

Last updated

2010-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study, pharmacokinetics parameters

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 .

Interventions

DRUGquetiapine fumarate extended-release

200mg,oral,single dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026