Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: quetiapine fumarate extended-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919607

D1444C00007

Details and patient eligibility

About

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 .

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

31 participants in 3 patient groups

1

Active Comparator group

Description:

quetiapine fumarate extended-release 300mg,administered once-daily Day1\~5

Treatment:

Drug: quetiapine fumarate extended-release

Drug: quetiapine fumarate extended-release

2

Experimental group

Description:

quetiapine fumarate extended-release 300mg/Day1,600mg/Day2\~6,administered once-daily

Treatment:

Drug: quetiapine fumarate extended-release

Drug: quetiapine fumarate extended-release

3

Experimental group

Description:

quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3\~7,administered once-daily

Treatment:

Drug: quetiapine fumarate extended-release

Drug: quetiapine fumarate extended-release