The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

Study Overview
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Brief Summary
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A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients

Official Title
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A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Drug: Evogliptin 5mg
* Drug: Evogliptin 5mg


Participation Criteria
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Eligibility Criteria
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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 group1(hemodialysis patients): MDRD-eGFR ≤ 15 mL/min/1.73m2 group2(helthy control): MDRD-eGFR ≥ 90 mL/min/1.73m2 Exclusion Criteria: Subjects who have a uncontrolled or unstable disease such as liver, nervous system, immune system, respiratory system, endocrine system or blood / tumor disease, cardiovascular disease, mental disorders (mood disorder, obsessive compulsive disorder, etc.) or history Subjects who have a gastrointestinal disease (such as Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or history of gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the test drug. Subjects with a history of significant hypersensitivity reaction such as anaphylaxis or angioedema to DPP-IV inhibitors Subjects who have AST (SGOT) and ALT (SGPT) greater than 1.5 times the upper limit of normal range, at the time of screening test including additional tests.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2) | Drug: Evogliptin 5mg<br>* 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<br>* Other names: Suganon;|
| Experimental: Group2<br>Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2) | Drug: Evogliptin 5mg<br>* Participants receive Single oral administration of Evogliptin 5mg on day1<br>* Other names: Suganon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |