This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 in healthy volunteers.
To healthy subjects of fifty-two (52), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D935 Test drug: CKD-385 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
52
D935 Cap. 1 Cap., single oral administration under fasting condition
CKD-385 Tab. 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-385/D935, from time zero up to the last measurable concentration.
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Cmax
The maximum concentration observed of CKD-385/D935 over blood sampling time.
Time frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
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