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Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: quetiapine fumarate extended-release (Drug); quetiapine fumarate extended-release (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tianmei Si, Principal Investigator, Affiliation: Peking University Institute of Mental Health

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 .

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

single dose PK parameters(300mg)

Steady-state multiple doses PK parameters

Secondary outcome:

Incidence and severity of AEs

Clinical significant change in Lab test

Clinical significant change in vital signs

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Beijing, Beijing, China
Additional Information

Starting date: June 2009
Last updated: March 25, 2010

Page last updated: August 23, 2015

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