Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT01924520
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2013-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Multiple-dose Study in Patients With Major Depressive Disorder
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with major depressive disorder (MDD).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: