Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
- Registration Number
- NCT00919607
- Lead Sponsor
- AstraZeneca
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3 quetiapine fumarate extended-release quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3\~7,administered once-daily 1 quetiapine fumarate extended-release quetiapine fumarate extended-release 300mg,administered once-daily Day1\~5 2 quetiapine fumarate extended-release quetiapine fumarate extended-release 300mg/Day1,600mg/Day2\~6,administered once-daily
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical significant change in Lab test baseline up to Day 9 Incidence and severity of AEs sign ICF to Day 9 Clinical significant change in vital signs baseline up to Day 9
Trial Locations
- Locations (1)
Research Site
🇨🇳Beijing, Beijing, China