Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610890
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To evaluate the pharmacokinetics of Hemay005 tablets on midazolam and its active metabolite α-hydroxymidazolam after multiple administration
2 Evaluate the effect of Hemay005 tablet on QT interval
3 To investigate the effect of Hemay 005 tablets on inflammatory factors
2 Evaluate the effect of Hemay005 tablet on QT interval
3 To investigate the effect of Hemay 005 tablets on inflammatory factors
Detailed Description:
1 To evaluate the pharmacokinetics of Hemay005 tablets on midazolam and its active metabolite α-hydroxymidazolam after multiple administration
2 Evaluate the effect of Hemay005 tablet on QT interval
3 To investigate the effect of Hemay 005 tablets on inflammatory factors
4 The safety of the subjects was evaluated
2 Evaluate the effect of Hemay005 tablet on QT interval
3 To investigate the effect of Hemay 005 tablets on inflammatory factors
4 The safety of the subjects was evaluated
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