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The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-375 | Drug | Test drug |
| |
| D387 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of Empagliflozin | Cmax of Empagliflozin | Time Frame: 0 hour ~ 48 hour after drug administration |
| Maximum plasma concentration of Metformin | Cmax of Metformin | Time Frame: 0 hour ~ 48 hour after drug administration |
| Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration | AUClast of Empagliflozin | Time Frame: 0 hour ~ 48 hour after drug administration |
| Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration | AUClast of Metformin | Time Frame: 0 hour ~ 48 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity | AUCinf of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Area under the plasma concentration of Metformin-time curve from time zero to infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung-Sang Yu, M.D.,Ph.D | Contact | +82-2-2072-1920 | ||
| Soyoung Lee, Pharmacist | Contact | +82-2-740-8872 | sylee0829@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Reference drug |
|
AUCinf of Metformin
| 0 hour ~ 48 hour after drug administration |
| Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration | Tmax of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Time to reach maximum (peak) plasma concentration of Metformin following drug administration | Tmax of Metformin | 0 hour ~ 48 hour after drug administration |
| Half-life of Empagliflozin | t1/2 of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Half-life of Metformin | t1/2 of Metformin | 0 hour ~ 48 hour after drug administration |
| Apparent clearance of Empagliflozin | CL/F of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Apparent clearance of Metformin | CL/F of Metformin | 0 hour ~ 48 hour after drug administration |
| Apparent volume of distribution of Empagliflozin | Vd/F of Empagliflozin | 0 hour ~ 48 hour after drug administration |
| Apparent volume of distribution of Metformin | Vd/F of Metformin | 0 hour ~ 48 hour after drug administration |
| D004700 | Endocrine System Diseases |