Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02815774
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-01-03
Brief Title:
SP2086 Pharmacokinetic Study in Renal Insufficiency Patients
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Parallel Open Phase Ih Study to Access the Pharmacokinetic of SP2086 in Renal Insufficiency Patients
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 SP2086 pharmacokinetic in Renal Insufficiency Patients
Detailed Description:
This trial adopt in a parallel open single dose study design The subject was divided into one of five groups according to the degree of renal Insufficiency which including normal mild moderate severe and end-stage All subjects were given SP2086 50mg and collected the blood samples before and after the 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