Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

Phase 1CompletedNCT00919607

AstraZeneca31 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

quetiapine fumarate extended-releaseDRUG

200mg,oral,single dose

quetiapine fumarate extended-releaseDRUG

300mg,oral,single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

single dose PK parameters(300mg)

Time frame: Day1 to 48 hour after Day 5

Steady-state multiple doses PK parameters

Time frame: Day 1 to 48 hours after Day7

Secondary Outcomes

Incidence and severity of AEs

Time frame: sign ICF to Day 9

Clinical significant change in Lab test

Time frame: baseline up to Day 9

Clinical significant change in vital signs

Time frame: baseline up to Day 9

Data from ClinicalTrials.gov

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