The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tenofovir Disoproxil Aspartate 1T PO
Tenofovir Disoproxil Fumarate 1T PO
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
AUCt of Tenofovir
Time frame: 0(Pre-dose) up to 72hr
AUCinf
Time frame: 0(Pre-dose) up to 72hr
Blood pressure
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
tmax
Time frame: 0(Pre-dose) up to 72hr
t1/2β
Time frame: 0(Pre-dose) up to 72hr
Clearance/F
Time frame: 0(Pre-dose) up to 72hr
Electrocardiography
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Physical Examination
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Pulse rate
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
Temperature
Time frame: 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day
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