This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 14 days Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
1 Tablet
1 Tablet
D013 1 Tablet, D326 1Tablet, D337 1 Tablet
H+ Yangji Hospita
Seoul, South Korea
AUCt of CKD-386
Area under the CKD-386 concentration in blood-time curve from 0 to t
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-386
The maximum CKD-386 concentration in blood sampling time t
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
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