Ignite Creation Date:
2024-05-06 @ 8:44 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02815748
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2016-01-03
Brief Title:
The Metabolite Identification and Material Balance Study of SP2086
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Single-center Randomized Open Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer
Status:
COMPLETED
Status Verified Date:
2016-06
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 purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers
Detailed Description:
All subjects were given SP2086 100mg only one time and blood sample should be collected before and 96 hours after medicine taken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None