BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the
 fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg
 x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended
 release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male
 volunteers.
This study will be conducted in separtes 2 Parts.

 Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
 of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
 (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
 extended release 1000 mg (500mg x 2 tablets) under fasting condition.

 Part II is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
 of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
 (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
 extended release 1000 mg (500mg x 2 tablets) under fed conditions.

 In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.

 the study design and arms are the same in both parts.
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)

 -  Subjects who are appropriate to conduct study procedure in the decision of
 investigator

 -  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, meurology, 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)