This study is a randomized, open-label, single dosing, 3-treatment, 6-sequence, 3-period, crossover-design study to compare the pharmacokinetics and safety of D113 with CKD-349 in healthy volunteers.
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: Entresto 200mg / Test drug: 1) CKD-349 F1 Tab. 2) CKD-349 F2 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
25
Chungnam National University Hospital
Daejeon, South Korea
AUCt of CKD-349, D113
Area under the CKD-349/D113 concentration in blood-time curve from zero to final
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-349, D113
The maximum CKD-349/D113 concentration in blood sampling time t
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
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