drug-drug interaction between DWP14012 and three different kinds of NSAIDs
to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
110
Seoul National University Hospital
Seoul, South Korea
RECRUITINGArm A, Cmax,ss of Celecoxib
Maximum measured plasma concentration at steady-state
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm A, AUCτ,ss of Celecoxib
Area under the plasma concentration-time curve
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm B, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm B, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm C, Cmax,ss of Naproxen
Maximum measured plasma concentration at steady-state
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm C, AUCτ,ss of Naproxen
Area under the plasma concentration-time curve
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm D, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm D, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
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Meloxicam 15mg, qd
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)
Arm E, Cmax,ss of Meloxicam
Maximum measured plasma concentration at steady-state
Time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Arm E, AUCτ,ss of Meloxicam
Area under the plasma concentration-time curve
Time frame: Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)
Arm D, Cmax,ss of DWP14012
Maximum measured plasma concentration at steady-state
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)
Arm D, AUCτ,ss of DWP14012
Area under the plasma concentration-time curve
Time frame: Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)