This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
complex single administration
co-administration of 2 drugs
Clinical Trial Center, Seoul National University Hospital
Seoul, South Korea
Area Under Curve(AUC)last of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Maximum of concentration (Cmax) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Time of maximum concentration(Tmax) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Terminal half-life(t1/2) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Apparent Clearance(CL/F) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Area Under Curve(AUC)inf of Evogliptin and Metformin
AUCinf = AUC last + Clast/λz
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
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