This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers.
36 healthy subjects are administration of D352 and D794 following each part. Pharmacokinetic blood samples are collected 1d to 22d. The drug-drug interaction and safety are assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
H Plus Yangji Hospital
Gwanak-gu, Seoul, South Korea
AUCtau,ss of D352(Part 1)
Area under the D352 concentration in blood-time curve in steady-state
Time frame: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
AUCtau,ss of D794(Part 2)
Area under the D794 concentration in blood-time curve in steady-state
Time frame: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
Cmax,ss of D352(Part 1)
The maximum D352 concentration in steady-state
Time frame: 1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour
Cmax,ss of D794(Part 2)
The maximum D794 concentration in steady-state
Time frame: 1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour
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