Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions
A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
1 Cap., single oral administration under fed condition
1 Tab., single oral administration under fed condition
1 Tab., single oral administration under fed condition
Central Hospital
Gyeonggi-do, Siheung-si, South Korea
AUCt of CKD-385
Area under the concentration-time curve from time zero to time of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Cmax of CKD-385
Maximum plasma concentration of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
AUCinf of CKD-385
Area under the concentration-time curve from zero up to infinity of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Tmax of CKD-385
Time to maximum plasma concentration of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
T1/2 of CKD-385
Terminal elimination half-life of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
CL/F of CKD-385
Apparent clearance of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Vd/F of CKD-385
Apparent Volume of Distribution of CKD-385
Time frame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
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