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A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2) |
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| Group2 | Experimental | Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin 5mg | Drug | Participants receive Single oral administration of Evogliptin 5mg on day1 |
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| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area Under the plasma Concentration versus time curve(AUClast) of Evogliptin | 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose |
| Cmax | Peak Plasma Concentration(Cmax) of Evogliptin | 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose |
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Inclusion Criteria:
Subjects who aged 20 to 80 at the time of screening
Subjects with 50.0kg≤Body Weight≤90.0kg and 18.0kg/m2≤BMI≤27.0kg/m2
Subjects who meet the following kidney functions
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
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| Evogliptin 5mg | Drug | Period 1(1d,After hemodialysis) → Wash-out period → Period 2(15d,Before hemodialysis) Hemodialysis patients receive Single oral administration of Evogliptin 5mg on day1 and day15 With a 14-day washout period |
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