This study evaluate the pharmacokinetic drug interactions and safety after co-administration of ilaprazole and NSAID in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Severance Hospital
Seoul, South Korea
Part 1
ilaprazole, naproxen Cmax,ss(Maximum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 1
ilaprazole, naproxen AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2
ilaprazole, aceclofenac Cmax,ss(Maximum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2
ilaprazole, aceclofenac AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3
ilaprazole, celecoxib Cmax,ss(Maximum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3
ilaprazole, celecoxib AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval (tau) at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
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Celecoxib 200mg
Part 1.
ilaprazole, naproxen Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 1.
ilaprazole, naproxen CLss/F(Apparent clearance of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 1.
ilaprazole, naproxen Vdss/F(Apparent volume of distribution at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 1.
ilaprazole, naproxen Cmin,ss(Minimum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 1.
ilaprazole, naproxen fluctuation
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2.
ilaprazole, aceclofenac Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2.
ilaprazole, aceclofenac CLss/F(Apparent clearance of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2.
ilaprazole, aceclofenac Vdss/F(Apparent volume of distribution at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2.
ilaprazole, aceclofenac Cmin,ss(Minimum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 2.
ilaprazole, aceclofenac fluctuation
Time frame: Predose(0hour), after dose 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3.
ilaprazole, celecoxib Tmax,ss(Time to maximum plasma concentration at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3.
ilaprazole, celecoxib CLss/F(Apparent clearance of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3.
ilaprazole, celecoxib Vdss/F(Apparent volume of distribution at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3.
ilaprazole, celecoxib Cmin,ss(Minimum concentration of drug in plasma at steady state)
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
Part 3.
ilaprazole, celecoxib fluctuation
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours