Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02815722
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-01-03
Brief Title:
The Drug-drug Interaction of SP2086 and Simvastatin
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Single Randomized OpenCross-over Phase Ig Study to Access the Drug-drug Interaction of SP2086 and Simvastatin
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 potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment in healthy adult volunteers
Detailed Description:
This is an open-label volunteers will know the names of treatments they are assigned single-center and cross-over study of SP2086 and Simvastatin in healthy adult volunteers All subject were randomized into two groups and the drugs will be administered according to the AB and BA sequences The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10 Simvastatin will be administered orally by mouth as 200mg on Day 6-Day10The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10 There were 5 days washout period between A and B The total time of this trial was 27 days
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