AME Study of [14C]-YH4808 in Healthy Male Subjects
NCT01825707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2014-07-14
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.
Conditions
- Healthy
Interventions
- DRUG
-
[14C]-YH4808 200 mg
\[14C\]-YH4808 200 mg (oral) on day1
Sponsors & Collaborators
-
Yuhan Corporation
lead INDUSTRY
Principal Investigators
-
Nicholas Siebers, M.D. · Covance Clinical Research Unit
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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