Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01082146
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2010-03-05
Brief Title:
RI-AME Study OF ISOTHIAZOLYL-3-14C-LURASIDONE
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A Phase 1 Study to Investigate the Absorption Metabolism and Excretion of Issthiazolyl-3-14C-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This will be an open-label non-randomized absorption metabolism and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
Detailed Description:
A Phase 1 Study to Investigate the Absorption Metabolism and Excretion of Isothiazolyl-3-14C-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects
Study Oversight
Has Oversight DMC:
None
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?:
None