A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Signed informed consent
- •Age: 19 and over , healthy volunteer
- •Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²
Exclusion Criteria
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
- •Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)
Arms & Interventions
Empagliflozin 25mg
- Period 1: Empagliflozin (QD, 5d)
- wash-out: 7d
- Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Intervention: Empagliflozin 25 MG (Drug)
Empagliflozin 25mg
- Period 1: Empagliflozin (QD, 5d)
- wash-out: 7d
- Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Intervention: Ezetimibe/Rosuvastatin 10/10mg (Drug)
Empagliflozin 25mg
- Period 1: Empagliflozin (QD, 5d)
- wash-out: 7d
- Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Intervention: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg (Drug)
Rosuvastatin/Ezetimibe 10/10mg
- Period 1: Ezetimibe/Rosuvastatin (QD, 7d)
- wash-out: 14d
- Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Intervention: Ezetimibe/Rosuvastatin 10/10mg (Drug)
Rosuvastatin/Ezetimibe 10/10mg
- Period 1: Ezetimibe/Rosuvastatin (QD, 7d)
- wash-out: 14d
- Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
Intervention: Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg (Drug)
Outcomes
Primary Outcomes
AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Time Frame: 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 Empagliflozin, Total Ezetimibe and Rosuvastatin
Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Time Frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration
Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin
Secondary Outcomes
- 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)
- 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)
- Cmax,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(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(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(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(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(0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hours of after administration)