Healthy Male Volunteers Clinical Trial
Official title:
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial 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 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.
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