A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843 in Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Severance Hospital
Seoul, South Korea
AUClast of CKD-843 A, CKD-843 B
Area under the concentration-time curve from time zero to last
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
AUCinf of CKD-843 A, CKD-843 B
Area under the concentration-time curve from zero up to ∞
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
AUC0-90days of CKD-843 A, CKD-843 B
Area under the concentration-time curve from time zero to 90 days
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
AUClast of CKD-843-R
Area under the concentration-time curve from time zero to last
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
AUCinf of CKD-843-R
Area under the concentration-time curve from zero up to ∞
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
AUC0-90days of CKD-843-R
Area under the concentration-time curve from time zero to 90 days
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Tmax of CKD-843 A, CKD-843 B
Time to maximum plasma concentration
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
t1/2 of CKD-843 A, CKD-843 B
Terminal elimination half-life
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
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CL/F of CKD-843 A, CKD-843 B
Apparent clearance
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Vd/F of CKD-843 A, CKD-843 B
Apparent volume of distribution
Time frame: Day 1(Pre-dose(0 hour), 2, 4, 8 12 hours)
Tmax of CKD-843-R
Time to maximum plasma concentration
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
t1/2 of CKD-843-R
Terminal elimination half-life
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
CL/F of CKD-843-R
Apparent clearance
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)
Vd/F of CKD-843-R
Apparent volume of distribution
Time frame: Day 1(Pre-dose(0 hour), 1, 2, 3, 4, 6, 8, 10, 12 hours)