A randomized, open-label, single dose, crossover study to evaluate pharmacokinetic profiles and safety/tolerability of CKD-357 in healthy volunteers
To healthy subjects of thirty(30), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Chonbuk National University Hospital
Jeonju, South Korea
AUCt of Ticagrelor
Area under the plasma concentration of Ticagrelor versus time curve from time zero to time of last quantifiable concentration
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Cmax of Ticagrelor
Maximum plasma concentration of Ticagrelor
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
AUCinf of Ticagrelor
Area under the plasma concentration of Ticagrelor versus time curve from time zero to time infinity
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Tmax of Ticagrelor
Time to maximum concentration of of Ticagrelor
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
t1/2 of Ticagrelor
Apparent terminal half-life of Ticagrelor
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
CL/F of Ticagrelor
Total body clearance of Ticagrelor
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
Vd/F of Ticagrelor
Apparent volume of distribution of Ticagrelor
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours
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AUCt of AR-C124910XX
Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time of last quantifiable concentration
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of AR-C124910XX
Maximum plasma concentration of AR-C124910XX
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
AUCinf of AR-C124910XX
Area under the plasma concentration of AR-C124910XX versus time curve from time zero to time infinity
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of AR-C124910XX
Time to maximum concentration of AR-C124910XX
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
t1/2 of AR-C124910XX
Apparent terminal half-life of AR-C124910XX
Time frame: Pre-dose(0 hour), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours