Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
Study NCT ID:
NCT06823232
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
Sponsor:
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Organization:
Study Overview
Official Title:
A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
Status:
COMPLETED
Status Verified Date:
2024-12
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 main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of \[14C\]XY0206, and to obtain data on human radioactive excretion rate and main excretion routes and the radioactivity of human plasma, urine, and faeces after oral administration of \[14C\]XY0206 by subjects Metabolite profiling, identification of major metabolites, determination of metabolic pathways and elimination pathways; Subjects who met the criteria fasted for at least 10h before administration and took \[14C\]XY0206 suspension (containing about 37.5mg/100µCi\[14C\]XY0206) orally on an empty stomach in the morning of the first day of administration (DI).Subjects will also complete urine, stool and blood collection within a specified period of time。
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: