BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.

Official Title
-----------------
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: gemigliptin and metformin HCl extended release
* Drug: gemigliptin/metformin HCl extended release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 19 to 45, healthy male subjects(at screening) Body weight between 55kg - 90kg, BMI between 18.0 - 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 3months Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently. Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G+M<br>Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets | Drug: gemigliptin and metformin HCl extended release<br>* Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets, for 1 day<br>|
| Experimental: C<br>Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets | Drug: gemigliptin/metformin HCl extended release<br>* Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Gemigliptin, Metformin |  | up to 48h post-dose | 
| AUCinf of Gemigliptin, Metformin |  | up to 48h post-dose | 
| t1/2 of Gemigliptin, Metformin |  | up to 48h post-dose | 
| CL/F of Gemigliptin, Metformin |  | up to 48h post-dose | 
| Vd/F of Gemigliptin, Metformin |  | up to 48h post-dose | 
| AUC0-48h of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| Cmax of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| Tmax of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| AUCinf of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| t1/2 of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| CL/F of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| Vd/F of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose | 
| metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636) |  | up to 48h post-dose |