Food-Effect Bioavailability Study of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)

Study Overview
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Brief Summary
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This study is designed to investigate the food-effects on FDC(gemigliptin/metformin HCl sustained release) 50/1000mg(25/500mg x 2tablets)

Official Title
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A Randomized, Open Label, Single Dose, Crossover Study to Investigate Food-effect Bioavailability of FDC(Gemigliptin/Metformin HCl Sustained Release) 50/1000mg(25/500mg x 2tablets)Under Fed and Fasting Conditions in Healthy Male Volunteers

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 to 45, healthy male subjects(at screening) BMI between 19.0 - 27.0 FPG 70-125mg/dL glucose level(at screening) Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress. Exclusion Criteria: Subject 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.) Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics) Subject who already participated in other trials in 90 days Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently. Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fasting condition | Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))<br> <br> |
| Experimental: B<br>FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mgx2tablets))under fed condition | Drug: FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | To evaluate AUClast of gemigliptin and metformin | up to 48 h post-dose | 
| Cmax | TO evaluate Cmax of gemigliptin and metformin | up to 48 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | To evaluate AUCinf of gemigliptin,metformin and LC15-0636(active metabolite of gemigliptin) | up to 48 h post-dose | 
| Tmax | To evaluate Tmax of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) | up to 48h post-dose | 
| t1/2 | To evaluate t1/2 of gemigliptin, metformin and LC15-0636(active metabolite of gemigliptim) | up to 48 h post-dose | 
| Cmax | To evaluate Cmax of LC15-0636(active metabolite of gemigliptim) | up to 48h post-dose | 
| AUClast | To evaluate AUClast of LC15-0636(active metabolite of gemigliptim) | up to 48h post-dose |