BE Study of the Combinations of Gemigliptin 50mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Detailed Description
-----------------
This study is to evaluate the safety/tolerability and pharmacokinetics(AUC and Cmax) of the combinations of gemigliptin 50mg and rosuvastatin 20mg in comparison to each component administered alone in healthy male volunteers.

Official Title
-----------------
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of the Combination of Gemigliptin/Rosuvastatin 50/20 mg in Comparison to Each Component Gemigliptin 50 mg and Rosuvastatin 20 mg Administered in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: gemigliptin 50mg, rosuvastatin 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 19 to 45, healthy male subjects(at screening) 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 2months Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently. Heavy smokers.(>10 cigarettes per day)

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: Coadministration of G+R<br>Coadministration of gemigliptin 50mg and rosuvastatin 20mg | Drug: gemigliptin 50mg, rosuvastatin 20mg<br>* gemigliptin/rosuvastatin 50/20mg<br>* Other names: Zemiglo, Cresto;|
| Experimental: Combination G/R<br>Combination of gemigliptin 50mg / rosuvastatin 20mg | Drug: gemigliptin 50mg, rosuvastatin 20mg<br>* gemigliptin/rosuvastatin 50/20mg<br>* Other names: Zemiglo, Cresto;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax | To evaluate AUClast/Cmax of gemigliptin and rosuvastatin | up to 72h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf | To evaluate AUCinf of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin | up to 72h post-dose | 
| Tmax | To evaluate Tmax of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin | up to 72h post-dose | 
| t1/2 | To evaluate t1/2 of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin | up to 72h post-dose | 
| CL/F | To evaluate CL/F of gemigliptin, LC15-0636 of gemigliptin metabolite and rosuvastatin | up to 72h post-dose | 
| metabolic ratio | To evaluate metabolic ratio of gemigliptin, LC15-0636 of gemigliptin metabolite | up to 72h post-dose | 
| AUEC | This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity. | up to 72h post-dose | 
| Emax | This parameter is been used to measure pharmarcodynamic characters of gemigliptin, the supression rate of DPP4 activity. | up to 72h post-dose |