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A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Evogliptin→Evogliptin+Empagliflozin→Empagliflozin |
|
| Group B | Experimental | Empagliflozin→Evogliptin→Evogliptin+Empagliflozin |
|
| Group C | Experimental | Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin |
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| Group D | Experimental | Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin→Evogliptin+Empagliflozin→Empagliflozin | Drug | Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD |
| Measure | Description | Time Frame |
|---|---|---|
| AUCτ,ss | area under the concentration-time curve | 4 weeks |
| Cmax,ss | maximum serum concentration | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min soo Park, M.D., Ph.D. | Clinical Trial Center, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Severance Hospital | Seoul | 03722 | South Korea |
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| Empagliflozin→Evogliptin→Evogliptin+Empagliflozin | Drug | Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD |
|
|
| Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin | Drug | Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD |
|
|
| Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin | Drug | Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD |
|
|
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
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