Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 25mg | Experimental |
|
|
| Rosuvastatin/Ezetimibe 10/10mg | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | PO, QD |
| |
| Ezetimibe/Rosuvastatin 10/10mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Ran Yoon, PhD | Contact | +82 53-200-6351 | yry@knu.ac.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national university hospital | Recruiting | Daegu | Gyeongsangbuk-do | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 sequence
Not provided
Not provided
Not provided
Not provided
| Drug |
PO, QD |
|
| Empagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg | Drug | PO, QD |
|
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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided