Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

Study Overview
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Brief Summary
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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

Detailed Description
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A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Official Title
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A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride
* Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male Volunteers (Age: 19 45years) 55<Body Weight<90, 18<BMI<27 FPG: 70-125 mg/dL Exclusion Criteria: galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Clinically significant Medical History Allergy or Drug Hypersensitivity AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min Drink during clinical trial period Smoking during clinical trial period Grapefruit/Caffeine intake during clinical trial period No Contraception

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Group A)<br>Evogliptin→Evogliptin+Glimepiride→Glimepiride | Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride<br>* 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<br>* Other names: Suganon, Amaryl;|
| Experimental: (Group B)<br>Glimepiride→Evogliptin→Evogliptin+Glimepiride | Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride<br>* 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.<br>* Other names: Suganon, Amaryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss for Evogliptin and Glimepiride | area under the concentration-time curve | 3 weeks |