A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348
A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
QD, PO
QD, PO
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
AUCt of CKD-348
AUCt: Area under the concentration-time curve from time zero to time
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Cmax of CKD-348
Cmax: Maximum plasma concentration of the drug
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
AUCinf of CKD-348
AUCinf: Area under the concentration-time curve from zero up to ∞
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
Tmax of CKD-348
Tmax: Time to maximum plasma concentration
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
T1/2 of CKD-348
T1/2: Terminal elimination half-life
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
AUCt/AUCinf of CKD-348
AUCt/AUCinf
Time frame: [Time Frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]
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