This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.
To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs. Investigate the effect of food on the pharmacokinetic characteristics of CKD-395
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)
Chonbuk National University Hospital
Deokjin-gu, Jeonju-si, 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
AUClast of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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
Cmax of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 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
AUCinf of Metformin
Time frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 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
Tmax of Metformin
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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 Metformin
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 Metformin
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 Metformin
Time frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs