A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 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 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers

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 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 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
* Drug: DA-1229_01 fast
* Drug: DA-1229_01 fed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 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: 20 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: (Part 1) DA-1229_01 → E+M<br>DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg | Drug: DA-1229_01<br>* complex single administration<br>* Other names: Evogliptin/Metformin XR 5/1000 mg;Drug: E+M<br>* co-administration of 2 drugs<br>* Other names: Evogliptin 5 mg + Metformin XR 1000 mg;|
| Experimental: (Part 1) E+M → DA-1229_01<br>DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg | Drug: DA-1229_01<br>* complex single administration<br>* Other names: Evogliptin/Metformin XR 5/1000 mg;Drug: E+M<br>* co-administration of 2 drugs<br>* Other names: Evogliptin 5 mg + Metformin XR 1000 mg;|
| Experimental: (Part 2) DA-1229_01 fast → fed<br>DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet | Drug: DA-1229_01 fast<br> <br> Drug: DA-1229_01 fed<br> <br> |
| Experimental: DA-1229_01 fed → fast<br>DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet | Drug: DA-1229_01 fast<br> <br> Drug: DA-1229_01 fed<br> <br> |

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 | 
| Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial) |  | 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose |