A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults
1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults. 2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
JW0201: single administration, Tablet, Oral, BID for 5 days
C2103: single administration, Tablet, Oral, BID for 5 days
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
Jeonbuk National University Hospita
Jeonju, Jeollabuk-do, South Korea
Cmax,ss
Cmax,ss of each drug
Time frame: up to 12hour(or 24hour) after administration
AUCτ,ss
AUCτ,ss of each drug
Time frame: up to 12hour(or 24hour) after administration
Cmin,ss
Cmin,ss of each drug
Time frame: up to 12hour(or 24hour) after administration
Tmax,ss
Tmax,ss of each drug
Time frame: up to 12hour(or 24hour) after administration
CLss/F
CLss/F of each drug
Time frame: up to 12hour(or 24hour) after administration
Vdss/F
Vdss/F of each drug
Time frame: up to 12hour(or 24hour) after administration
fluctuation
fluctuation of each drug
Time frame: up to 12hour(or 24hour) after administration
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C2104 : single administration, Tablet, Oral, QD for 5 days
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days