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

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fasting Conditions

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: IY-NT-T; Drug: IY-NT-R

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08756
      • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A group; Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : Ilaprazole 20mg 1Tab, one a day	Drug: IY-NT-T; Ilaprazole 20mg; Drug: IY-NT-R; Ilaprazole 10mg; Other Names: Noltec(the brand name)
Active Comparator: B group; Period 1 : Ilaprazole 20mg 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day	Drug: IY-NT-T; Ilaprazole 20mg; Drug: IY-NT-R; Ilaprazole 10mg; Other Names: Noltec(the brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ilaprazole AUCt	ilaprazole AUCt(Area under the concentration-time curve)	Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole Cmax	ilaprazole Cmax(Maximum concentration of drug in plasma)	Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ilaprazole AUC∞	ilaprazole AUC∞(Area under the plasma drug concentration-time curve from time 0 to infinity)	Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole tmax	ilaprazole tmax(Time to maximum plasma concentration)	Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours
Ilaprazole t1/2	ilaprazole t1/2(Terminal elimination half-life)	Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Principal Investigator: Jae Woo Kim, MD, PhD, H Plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): October 22, 2022
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: proton pump inhibitor
• Other Study ID Numbers: DTC22-IP017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No