This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.
To healthy male 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: D308 10mg Tab. / Test drug: CKD-380 10mg 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
34
D308 10mg Tab.1T single oral administration under fasting condition
CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
AUCt of CKD-380 and D308
Area under the CKD-380/D308 concentration in blood-time curve from zero to the final
Time frame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
Cmax of CKD-380 and D308
The maximum CKD-380/D308 concentration in blood sampling time t
Time frame: Pre-dose(0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours
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