This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days. Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucophage XR Tab. 500mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration
CKD-395 0.25/500mg 2T oral administration
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
AUClast of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUClast of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Cmax of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
AUCinf of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Tmax of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
CL/F of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Vd/F of Lobeglitazone
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUCinf of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Tmax of Metformin
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Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
t1/2 of Lobeglitazone
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
CL/F of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs
Vd/F of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24 and 48hrs