ClinicalTrials.gg
Status unknownNCT05617651Updated Mar 1, 2023

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

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

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Pharmacokinetics

Keywords

  • proton pump inhibitor
03

In context

Lead sponsor

Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    A group

    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

  • Active comparator
    B group

    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

Interventions

  • DrugIY-NT-T

    Ilaprazole 20mg

  • Ilaprazole 10mg

    Also known as: Noltec(the brand name)

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 site
  • H plus Yangji Hospital
    Seoul, Gwanak-gu 08756, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05617651
Responsible party
Sponsor
First posted
Nov 15, 2022
Start date
Nov 30, 2024 (estimated)
Primary completion
Dec 10, 2024 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Mar 1, 2023

Study contacts

Jung Hwa Hong, bachelor
Contact
jhhong@ilyang.co.kr
+82.2.570.3777
Yun Ho Kwon, bachelor
Contact
yhkwon@ilyang.co.kr
+82.2.570.3795
Jae Woo Kim, MD, PhD
principal investigator · H Plus Yangji Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ilaprazole

Start the discussion