Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03977805
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2019-05-05
Brief Title:
Metabolism and Disposition of 14C Herombopag in Chinese Healthy Human Subjects
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
Metabolism and Disposition of 14C Herombopag in Chinese Healthy Human Subjects
Status:
COMPLETED
Status Verified Date:
2020-05
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:
This study is a single-center open-label single-dose design It is planning to enroll six Chinese healthy adult male subjects The metabolism and disposition of Herombopag will be studied in these subjects after a single oral administration of a solution dose of 14C Herombopag 5 mg 100 uCi
Detailed Description:
The metabolism and disposition of Herombopag will be studied in six healthy men after a single oral administration of a solution dose of 14Celtrombopag 5 mg100 uCi
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma quantitatively analyze the the total radioactivity in the excretaevaluate the predominant route of elimination and indentify the Metabolite profiles in plasma urine and faces
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma quantitatively analyze the the total radioactivity in the excretaevaluate the predominant route of elimination and indentify the Metabolite profiles in plasma urine and faces
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?:
None