Oral Multiple-dose Study in Patients With Major Depressive Disorder
NCT01924520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2017-02-16
Summary
A study was to evaluate the safety and plasma concentration changes of quetiapine after repeated administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).
Conditions
Interventions
- DRUG
-
FK949E
Oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Inc
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2011-05-31
- Completion
- 2011-05-31
Countries
- Japan
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