Severance Hospital
Seoul, South Korea
NCT Number: NCT05237297
This study evaluate the pharmacokinetic drug interactions and safety after co-administration of ilaprazole and NSAID in healthy adults.
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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Seoul, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
※ Body mass index (kg/m2) = Weight (kg)/[Height (m)]2
Exclusion criteria
Ilaprazole 10mg
Other names: Noltec(the brand name)
Naproxen 500mg
Other names: Naxen-F(the brand name)
Aceclofenac 100mg
Other names: Airtal(the brand name)
Celecoxib 200mg
Other names: Celebrex(the brand name)
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
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
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
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
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 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
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
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 0.5hour, 0.75hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
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
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
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
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
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
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
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
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
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
ilaprazole, aceclofenac fluctuation
Time frame: Predose(0hour), after dose 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 5hours, 6hours, 8hours, 10hours, 12hours
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
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
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
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
ilaprazole, celecoxib fluctuation
Il-Yang Pharm. Co., Ltd.
Industry
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Co-administration of Ilaprazole and NSAID in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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