Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05675202
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Material Balance Study of TQ-B3525
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
Clinical Trial on Absorption, Metabolism and Excretion of [14C] TQ-B3525 in Chinese Adult Male Healthy Subjects - Research on Material Balance and Biotransformation of [14C] TQ-B3525
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_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:
A clinical study to investigate the absorption, metabolism and excretion of \[14C\] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of \[14C\] TQ-B3525, obtain the data of human radioactive excretion rate and main drainage routes, investigate the distribution in whole blood and plasma, the distribution in plasma and the pharmacokinetics of total radioactivity in plasma, and identify the main metabolites, To determine the main biotransformation pathway and obtain the pharmacokinetic parameters of TQ-B3525 and its metabolites in plasma.
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?:
None
Is an FDA AA801 Violation?: