The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
PK101-001 + PK101-002 (combination)
coadministration
Clinical Trials Center, Chungnam National University Hospital
Daejeon, South Korea
AUCt
Area under the plasma/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Cmax
Maximum Plasma Concentration of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Tmax
Time of peak concentration of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
AUCinf
Area under the plasma concentration versus time curve from zero to infinity of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
t1/2
Terminal half life of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
CL/F
Clearance/Bioavailability of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
AUCt/AUCinf
AUCt/AUCinf of PK101-002
Time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
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