Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Study Overview
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Brief Summary
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A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

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

Official Title
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A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone
* Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone
* Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone
* Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin
* Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone
* Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin


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: A group<br>Evogliptin Pioglitazone Evogliptin+Pioglitazone | Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone<br>* Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD<br>* Other names: Actos;|
| Experimental: B group<br>Pioglitazone Evogliptin Evogliptin+Pioglitazone | Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone<br>* Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD<br>* Other names: Actos;|
| Experimental: C group<br>Evogliptin Evogliptin+Pioglitazone Pioglitazone | Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone<br>* Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD<br>* Other names: Actos;|
| Experimental: D group<br>Pioglitazone Evogliptin+Pioglitazone Evogliptin | Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin<br>* Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD<br>* Other names: Actos;|
| Experimental: E group<br>Evogliptin+Pioglitazone Evogliptin Pioglitazone | Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone<br>* Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD<br>* Other names: Actos;|
| Experimental: F group<br>Evogliptin+Pioglitazone Pioglitazone Evogliptin | Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin<br>* Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD<br>* Other names: Actos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | area under the concentration-time curve | 1d 6d pre-dose, 15d 20d pre-dose, 29 34d pre-dose, 7d/21d/35d pre-dose and post-dose |