This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
single oral administration under fed condition
single oral administration under fed condition
single oral administration under fed condition
Korea University Anam Hospital
Seoul, South Korea
AUCt of CKD-501, D759, D150, CKD-393
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final
Time frame: Time Frame: 0 hour ~ 48 hours
Cmax of CKD-501, D759, D150, CKD-393
The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t
Time frame: Time Frame: 0 hour ~ 48 hours
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