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This is a randomized, open-label, single dose, crossover, phase â… trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
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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-379(Empagliflozin+sitagliptin+metformin) Test drug | Drug | oral, once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration | |
| Cmax of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration | |
| Tmax of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaeyong Jeong | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea |
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| CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug |
| Drug |
oral, once |
|
| t1/2 of Empagliflozin, sitagliptin, metformin |
| 0 hour ~ 48 hour after drug administration |
| CL/F of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration |
| Vd/F of Empagliflozin, sitagliptin, metformin | 0 hour ~ 48 hour after drug administration |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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