The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers.
To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Duvie Tab. 0.5mg\*1T/day for 5days, QD, PO
Duvie Tab. 0.5mg + Januvia Tab.100mg\*1T/day for 5 dyas, QD, PO
Chonbuk National University Hospital
Jeonju, South Korea
AUCτ of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,max of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,min of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,av of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Tss,max of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
t1/2 of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
CLss/F of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Vdss/F of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
fluctuation[(Css,max-Css,min)/Css,av] of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
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swing[(Css,max-Css,min)/Css,min] of Lobeglitazone
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h