gemigliptin,SGLT-2i DDI study
LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin \& dapagliflozin and gemigliptin \& empagliflozin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
zemiglo 50mg,LG Chem
forxiga, dapagliflozin 10mg
jardiance 25mg, empagliflozin
LG chem
Seoul, Gangseo-Gu, South Korea
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin
AUCτ
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin
Css,max
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
tss,max of gemigliptin, dapagliflozin, empagliflozin
tss,max
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin
Css,min
Time frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite
AUCτ
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Peak Plasma Concentration (Cmax)of gemigliptin metabolite
Css,max
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
minimum blood plasma concentration(Css,min) of gemigliptin metabolite
Css,min
Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
metabolic ratio of gemigliptin
metabolic ratio
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Time frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours