A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-398
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-398 in healthy volunteers under fasting conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Test Drug
Reference Drug
Chonbuk National University Hospital
Jeonju, South Korea
AUCt of CKD-398
Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Cmax of CKD-398
The maximum concentration observed of CKD-344 over blood sampling time.
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
AUCinf of CKD-398
Area under the concentration-time curve from zero up to ∞
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Tmax of CKD-398
Time to maximum plasma concentration
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
T1/2 of CKD-398
Terminal elimination half-life
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
CL/F of CKD-398
Apparent Clearance
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Vd/F of CKD-398
Apparent volume of distribution
Time frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-dose
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