Viewing Study NCT06578676



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

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