Dyslipidemias, Type 2 Diabetes
Conditions
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.
Interventions
DRUGEmpagliflozin 25 MG
PO, QD
DRUGEzetimibe/Rosuvastatin 10/10mg
PO, QD
DRUGEmpagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg
PO, QD
Sponsors
Kyungpook National University Hospital
Hyundai Pharm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
2 sequence
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Cmax,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 | AUCtau,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | AUCtau,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 | AUCinf,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 | Tmax,ss 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 | Vdss/F 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 | t1/2,ss 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 | CLss/F 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 | Cmin,ss of Free ezetimibe, Empagliflozin, Total ezetimibe and Rosuvastatin |
| 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 | Cmax,ss, AUCtau,ss, AUCinf,ss, Tmax,ss, Cmin,ss, t1/2,ss, CLss/F, Vdss/F of Free ezetimibe |
Countries
South Korea
Contacts
Primary ContactYoung-Ran Yoon, PhD
Outcome results
None listed