NCT06578676

To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Hyundai Pharm · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg Ezetimibe/Rosuvastatin 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 10/10mg of Ezetimibe/Rosuvastatin 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 5days(Period 1). After 7days of washout period, the subjects take 10/10mg of Ezetimibe/Rosuvastatin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days. In Arm B, 38 subjects will be assigned. The subjects take 10/10mg of Ezetimibe/Rosuvastatin for 7days(Period 1). After 14days of washout period, the subjects take 25mg of empagliflozin for 2days and take co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin for 5days.

Conditions

• Type 2 Diabetes
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Empagliflozin 25 MG	PO, QD
DRUG	Ezetimibe/Rosuvastatin 10/10mg	PO, QD
DRUG	Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg	PO, QD

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-09-02
• Completion: 2024-11-30
• First posted: 2024-08-29
• Last updated: 2024-08-29

Locations

1 site across 1 country: South Korea