A Phase 1 interventional study of IY-NT-T and IY-NT-R in Pharmacokinetics, sponsored by Il-Yang Pharm. Co., Ltd.. Status unknown at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 1, Interventional, and Treatment
This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults
Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fed condition
Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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A volunteer who weighs ≥ 50kg (≥ 45kg for women) and has a body mass index(BMI)* of ≥18.0 and ≤ 30 at screening
*BMI(body mass index, kg/m\^2)= Body weight (kg)/[height (m)\^2]
A volunteer and their spouse or partner, who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of study drug
* Contraception methods: Intrauterine device, vasectomy, tubal ligation and contraceptive barrier methods (male condoms, women condoms, cervical caps. Contraceptive diaphragm, sponge,etc) used in combination or if spermicide is used, two or more contraceptive barrier methods
Exclusion Criteria:
A volunteer that meets any of the following conditions within 1 month prior to first dose
A volunteer that meets any of the following categories
Patients that meet any of the following conditions
Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : Ilaprazole 20mg 1Tab, one a day Period 3 : Ilaprazole 10mg 2Tab, one a day
Drug: IY-NT-T · Drug: IY-NT-R
Period 1 : Ilaprazole 20mg 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day Period 3 : Ilaprazole 20mg 1Tab, one a day
Drug: IY-NT-T · Drug: IY-NT-R
Ilaprazole 20mg
Ilaprazole 10mg
Also known as: Noltec(the brand name)
Ilaprazole AUCt
ilaprazole AUCt(Area under the concentration-time curve)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole Cmax
ilaprazole Cmax(Maximum concentration of drug in plasma)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole AUC∞
ilaprazole AUC∞(Area under the plasma drug concentration-time curve from time 0 to infinity)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole tmax
ilaprazole tmax(Time to maximum plasma concentration)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole t1/2
ilaprazole t1/2(Terminal elimination half-life)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole tmax-tlag
Ilaprazole tmax-tlag (Time to maximum plasma concentration minus Lag time)
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Ilaprazole intra-subject tlag difference
Ilaprazole intra-subject Lag time difference
Time frame: Predose(0hour), after dose 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 34, 36, 40, 48 hour
Plan to share: No
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ilaprazole