To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
NCT Number: NCT06578676
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Type 2 Diabetes|Dyslipidemias
Interventions: DRUG: Empagliflozin 25 MG|DRUG: Ezetimibe/Rosuvastatin 10/10mg|DRUG: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
Sponsor: Hyundai Pharm
Collaborators: Kyungpook National University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06-20
Completion Date: 2024-11-30
Locations: Kyungpook national university hospital, Daegu, Gyeongsangbuk-do, Korea, Republic of

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.

Primary Outcome Measures: Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration|AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration
Secondary Outcome Measures: Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Vdss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Cmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Cmax,ss, AUCtau,ss, AUCinf,ss, Tmax,ss, Cmin,ss, t1/2,ss, CLss/F, Vdss/F of Free ezetimibe, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, AUCtau,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, AUCinf,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Tmax,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, t1/2,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration|CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, CLss/F of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin, 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration