This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-389 in healthy volunteers.
To healthy subjects of thirty-four (34), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug(D759 and D308), Test drug(CKD-389) Pharmacokinetic blood samples are collected up to 48 hrs. The pharmacokinetic characteristics and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
D759 Tab. 1 Tab. and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.
Chonbuk National University Hospital
Jeonju, South Korea
AUCt(Area Under Curve last)
Area under the plasma concentration time curve of CKD-389/D759\&D308, from time zero up to the last measurable concentration.
Time frame: Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
Cmax
The maximum concentration observed of CKD-389/D759\&D308 over blood sampling time.
Time frame: Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
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