The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.
The pharmacokinetics and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Fasting + DWN12088 200 mg
30 minutes after a high-fat meal + DWN12088 200 mg
2 hours after a high-fat meal + DWN12088 200 mg
Seoul National University Hospital
Seoul, South Korea
Cmax of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
AUClast of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
Adverse events (AEs) such as subjective and objective symptoms
To evaluate safety
Time frame: follow-up 26 days after dosing
AUCinf of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
Tmax of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
t1/2 of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
Vd/F of DWN12088 and metabolite
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To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours
CL/F of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Time frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours