Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05868967
Status:
UNKNOWN
Last Update Posted:
2023-05-22
First Post:
2023-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Organization:
Study Overview
Official Title:
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 investigate the Mass Balance and Biotransformation of \[14C\]DWP14012 in Healthy Chinese Male Subjects
Detailed Description:
This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of \[14C\]DWP14012 suspension (containing approximately 40 mg/80 μCi \[14C\]DWP14012) under the fasting conditions
Study Oversight
Has Oversight DMC:
None
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?: