Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578676
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 1010mg EzetimibeRosuvastatin in steady state in healthy volunteers
Detailed Description:
This trial is a phase 1 study to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 1010mg of EzetimibeRosuvastatin in steady state in healthy volunteers
This is open-label multiple-dose two-arm two-period and fixed-sequence design
In Arm A 18 subjects will be assigned The subjects take 25mg of empagliflozin for 5daysPeriod 1 After 7days of washout period the subjects take 1010mg of EzetimibeRosuvastatin for 2days and take co-administrated 25mg of Empagliflozin and 1010mg of EzetimibeRosuvastatin for 5days
In Arm B 38 subjects will be assigned The subjects take 1010mg of EzetimibeRosuvastatin for 7daysPeriod 1 After 14days of washout period the subjects take 25mg of empagliflozin for 2days and take co-administrated 25mg of Empagliflozin and 1010mg of EzetimibeRosuvastatin for 5days
This is open-label multiple-dose two-arm two-period and fixed-sequence design
In Arm A 18 subjects will be assigned The subjects take 25mg of empagliflozin for 5daysPeriod 1 After 7days of washout period the subjects take 1010mg of EzetimibeRosuvastatin for 2days and take co-administrated 25mg of Empagliflozin and 1010mg of EzetimibeRosuvastatin for 5days
In Arm B 38 subjects will be assigned The subjects take 1010mg of EzetimibeRosuvastatin for 7daysPeriod 1 After 14days of washout period the subjects take 25mg of empagliflozin for 2days and take co-administrated 25mg of Empagliflozin and 1010mg of EzetimibeRosuvastatin for 5days
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