Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01825707
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2013-03-14
Brief Title:
AME Study of 14C-YH4808 in Healthy Male Subjects
Sponsor:
Yuhan Corporation
Organization:
Yuhan Corporation
Study Overview
Official Title:
A Phase I Study to Investigate the Absorption Metabolism and Excretion of 14C-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2014-07
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:
The purpose of this study is to determine the absorption metabolism and excretion AME kinetics of YH4808 and to determine and characterize metabolites present in plasma urine and feces in man following a single dose of 14C YH4808 200 mg 100 µCi 20 µCi administered as a single oral dose
Detailed Description:
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry ie prior to Check-in Day -1 Subjects will be confined at the Clinical Research Unit CRU from Check in Day -1 until Discharge Criteria have been met as early as Day 6 and as late as Day 11 In this study design physical examinations electrocardiograms ECGs vital signs How do you feel HDYF Inquiries and clinical laboratory evaluations will be performed at Screening at specified times during the study andor at Clinic Discharge All AEs whether volunteered elicited or noted on physical examination will be recorded throughout the study ie from dosing on Day 1 until Clinic Discharge Day 11
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