Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

Study Overview
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Brief Summary
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A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Official Title
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A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
* Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
* Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
* Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health Male Volunteers (Age : 19 55 years) Body Weight≥55kg, 18.5≤BMI<25.0 Exclusion Criteria: galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Allergy or Drug hypersensitivity Clinically significant Medical History AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73㎡ 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: 55 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+Empagliflozin→Empagliflozin | Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin<br>* Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD<br>* Other names: Jardiance;|
| Experimental: Group B<br>Empagliflozin→Evogliptin→Evogliptin+Empagliflozin | Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin<br>* Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD<br>* Other names: Jardiance;|
| Experimental: Group C<br>Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin | Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin<br>* Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD<br>* Other names: Forxiga;|
| Experimental: Group D<br>Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin | Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin<br>* Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD<br>* Other names: Forxiga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ,ss | area under the concentration-time curve | 4 weeks | 
| Cmax,ss | maximum serum concentration | 4 weeks |