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A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects
A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Group A) | Experimental | Evogliptin→Evogliptin+Glimepiride→Glimepiride |
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| (Group B) | Experimental | Glimepiride→Evogliptin→Evogliptin+Glimepiride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin→Evogliptin+Glimepiride→Glimepiride | Drug | Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days. Glimepiride : Glimepiride 4mg QD Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD |
| Measure | Description | Time Frame |
|---|---|---|
| AUCĎ„,ss for Evogliptin and Glimepiride | area under the concentration-time curve | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D., Ph.D. | Clinical Trial Center, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
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| Glimepiride→Evogliptin→Evogliptin+Glimepiride | Drug | After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. |
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