A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
QD, PO
QD, PO
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
AUCt of CKD-386
AUCt: Area under the concentration-time curve from time zero to time
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Cmax of CKD-386
Maximum plasma concentration of the drug
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
AUCinf of CKD-386
AUCinf: Area under the concentration-time curve from zero up to ∞
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
Tmax of CKD-386
Tmax: Time to maximum plasma concentration
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
AUCt/AUCinf of CKD-386
AUCt/AUCinf
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
T1/2 of CKD-386
T1/2: Terminal elimination half-life
Time frame: Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours
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