This study comparative evaluation of safety and pharmacokinetic and pharmacodynamic properties in oral repeat administration of IY-NS250 and IY-NT-SR in healthy adult
Not provided
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Chungbuk National University Hospital
Seoul, Seowon-gu, South Korea
Ilaprazole AUCτ,ss
Ilaprazole AUCτ,ss
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
integrated gastric acidity
Percentage decrease in integrated gastric acidity over 24 hours from Day -1 to Day 7
Time frame: Day -1 -24hour ~ 0h Day7 Predose(0hour) ~ 24hour
AUCinf,ss
AUCinf,ss, of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Cmax,ss
Cmax,ss of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Cmin,ss
Cmin,ss of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Cav,ss
Cav,ss of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tmax,ss
Tmax,ss of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
t1/2,ss
t1/2,ss of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
CLss/F
CLss/F of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Vss/F, R (accumulation ratio)
Vss/F, R (accumulation ratio) of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
PTF (Peak to Trough fluctuation)
PTF (Peak to Trough fluctuation) of Ilaprazole after repeated administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour / Day 5, Day 6 Predose(0hour) / Day 7 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Cmax
Cmax of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
AUClast
AUClast of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
AUCinf
AUCinf of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Tmax
Tmax of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
t1/2
t1/2 of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
CL/F
CL/F of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
Vz/F
Vz/F of Ilaprazole after single administration
Time frame: Day 1 Predose(0hour), after dose 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hour
integrated gastric acidity
Percentage decrease in integrated gastric acidity at different time points from Day -1 to Day 1 and Day 7
Time frame: Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour
nocturnal acid breakthrough (NAB)
Percentage of subjects experiencing nocturnal acid breakthrough (NAB) on Day -1, Day 1, and Day 7, defined as maintaining a pH below 4 for more than 60 consecutive minutes during nighttime (supine position)
Time frame: Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour