Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-28 @ 11:24 AM
Study NCT ID:
NCT03381703
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2017-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2016-05
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 study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects
Detailed Description:
Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.
Part 2
: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
Part 2
: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: