Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-27 @ 4:37 AM
Study NCT ID:
NCT02815657
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Drug-drug Interaction of SP2086 and Valsartan
Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
A Single Randomized, Open,Cross-over, Phase I Study to Access the Drug-drug Interaction of SP2086 and Valsartan
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 Valsartan after 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 Valsartan in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences, all subjects must completed the two stages(A and B). The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12.There were 6 days washout period between the two stages. The whole study needs 31 days.
Study Oversight
Has Oversight DMC:
False
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?: