Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
Open-label, Randomized, 3-period, 6-sequence, crossover study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
after taking Standard meal, CKD-519 50mg 2Tabs. administration.
after taking Standard meal, CKD-519 100mg 1Tab. administration.
after taking Standard meal, CKD-519 100mg 1Cap. administration.
Korea university medical center
Seoul, Sungbuk-gu, South Korea
Cmax of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Tmax of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
AUClast of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
AUC0-∞ of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
t1/2 of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
CL/F of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Vd/F of CKD-519
Time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
Tmax of CKD-519 CETP Activity
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
AUEC of CKD-519 CETP Activity
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
EC50(half maximal effective concentration ) of CKD-519 CETP Activity
Time frame: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
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