A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers

Study Overview
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Brief Summary
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This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).

Official Title
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A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 (Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg After Single Oral Administration in Healthy Male Volunteers

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: DA-1229_01
* Drug: E+M


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 to 45, healthy male subjects(at screening) Body weight between 55kg - 90kg, BMI between 18.0 - 27.0 FPG 60-125mg/dL glucose level(at screening) Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. Exclusion Criteria: Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder) Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded) Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction Subject who already participated in other trials in 2 months Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-1229_01 → E+M<br>DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg | Drug: DA-1229_01<br>* complex single administration<br>* Other names: Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets;Drug: E+M<br>* co-administration of 2 drugs<br>* Other names: Evogliptin 5 mg + Metformin XR 1000 mg;|
| Experimental: E+M → DA-1229_01<br>DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg | Drug: DA-1229_01<br>* complex single administration<br>* Other names: Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets;Drug: E+M<br>* co-administration of 2 drugs<br>* Other names: Evogliptin 5 mg + Metformin XR 1000 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve(AUC)last of Evogliptin and Metformin |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | 
| Maximum of concentration (Cmax) of Evogliptin and Metformin |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum concentration(Tmax) of Evogliptin and Metformin |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | 
| Terminal half-life(t1/2) of Evogliptin and Metformin |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | 
| Apparent Clearance(CL/F) of Evogliptin and Metformin |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose | 
| Area Under Curve(AUC)inf of Evogliptin and Metformin | AUCinf = AUC last + Clast/λz | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |