Evaluate the pharmacokinetics of Quetiapine fumarate in Chinese schizophrenic patients
Study identifier:D1444C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
-
Medical condition
schizophrenia
Phase
Phase 1
Healthy volunteers
No
Study drug
quetiapine fumarate extended-release
Sex
All
Actual Enrollment
31
Study type
Interventional
Age
18 Years - 60 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Mar 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 quetiapine fumarate extended-release 300mg,administered once-daily Day1~5 | Drug: quetiapine fumarate extended-release 300mg,oral,single dose Other Name: SEROQUEL XR |
| Experimental: 2 quetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily | Drug: quetiapine fumarate extended-release 300mg,oral,single dose Other Name: SEROQUEL XR |
| Experimental: 3 quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily | Drug: quetiapine fumarate extended-release 200mg,oral,single dose Other Name: SEROQUEL XR Drug: quetiapine fumarate extended-release 300mg,oral,single dose Other Name: SEROQUEL XR |
Contacts
Investigators
Principal Investigator
Tianmei Si
Peking University Institute of Mental Health
