Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T

Phase 1

Not yet recruiting

• Conditions: Pharmacokinetics
• Interventions: Drug: IY-NT-T; Drug: IY-NT-R

• Registration Number: NCT05617651
• Lead Sponsor: Il-Yang Pharm. Co., Ltd.

Brief Summary

This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults

Detailed Description

Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fed condition

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01
• Study Start: 2024-11-30
• Primary Completion: 2024-12-10
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Volunteers aged 19 years and above at screening

2. 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]

3. A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening

4. A volunteer who is determined by the principal investigator or sub-investigator(responsible physician) as eligible as a subject based on diagnostic tests( hematology, hematochemical, serum, urinalysis) and electrocardiogram tests established and conducted according to the characteristics of the study drug

5. 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

6. A volunteer who voluntarily provided written consent to participation in the entire study process after being fully informed of the study objective, contents, characteristics of the study drugs, and expected adverse reactions, prior to study participation

Exclusion Criteria

1. A volunteer who has a history or present symptoms of clinically significant disorders relating to any of the following: digestive system, cardiovascular system, endocrine system, respiratory system, blood and lymphatic, infectious disease, renal, urinary, and reproductive, system, nervous system, musculoskeletal system, immune system, otolaryngology, skin and subcutaneous tissue system, and ophthalmic system

2. A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases

3. A volunteer who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first dose or who has taken drugs that may interfere with clinical study within 10 days prior to the first dose(Provided that, participation may be considered based on drug-drug interaction, pharmacokinetics and pharmacodynamics(such as half-life) of study drug)

4. A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug

5. A volunteer who has participated in whole blood donation within 8 weeks prior to first dose, or apheresis donation within w weeks prior to first dose, or received blood donation within 4 weeks prior to first dose.

6. A volunteer that meets any of the following conditions within 1 month prior to first dose

   • Average alcohol intake(for men): > 21 glass/week
   • Average alcohol intake(for women): > 14 glass/week (1 glass = 50ml of soju or 30ml of liquor, or 250ml of beer)
   • Average cigarette smoking: > 20 cigarettes per day.

7. A volunteer that meets any of the following categories

   • Volunteer who is hypersensitive to the active ingredient or other ingredients of this drug

8. Patients that meet any of the following conditions

   • Gastric ulcer patients possibly related to a malignant tumor
   • Hepatic disorder or renal disorder patients
   • Patients receiving Atazanavir
   • Patients receiving Rilpivirine-containing products

9. A volunteer who is considered by the investigator to be ineligible to participate in this study for other reasons

10. Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A group	IY-NT-R	Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : Ilaprazole 20mg 1Tab, one a day Period 3 : Ilaprazole 10mg 2Tab, one a day
A group	IY-NT-T	Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : Ilaprazole 20mg 1Tab, one a day Period 3 : Ilaprazole 10mg 2Tab, one a day
B group	IY-NT-T	Period 1 : Ilaprazole 20mg 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day Period 3 : Ilaprazole 20mg 1Tab, one a day
B group	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

Primary Outcome Measures

Name	Time	Method
Ilaprazole AUCt	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 AUCt(Area under the concentration-time curve)
Ilaprazole Cmax	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(Maximum concentration of drug in plasma)

Secondary Outcome Measures

Name	Time	Method
Ilaprazole t1/2	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(Terminal elimination half-life)
Ilaprazole AUC∞	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∞(Area under the plasma drug concentration-time curve from time 0 to infinity)
Ilaprazole tmax	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(Time to maximum plasma concentration)
Ilaprazole intra-subject tlag difference	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 Lag time difference
Ilaprazole tmax-tlag	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 (Time to maximum plasma concentration minus Lag time)

Trial Locations

Locations (1)

H plus Yangji Hospital; 🇰🇷 Seoul, Gwanak-gu, Korea, Republic of