PharmacokineticsPhase 1NCT06725992

Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-NS250 and IY-NT-SR

A Phase 1 study testing IY-NS250 and IY-NT-SR in people with Pharmacokinetics and Pharmacodynamics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics, Pharmacodynamics
What is being tested?: IY-NS250 and IY-NT-SR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteSouth Korea
Study dates: 30 Jan 2024to 14 Aug 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult volunteers aged 19 years or older at screening
Individuals with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 at screening
BMI (kg/m2) = Weight (kg) / {Height (m)}2
ndividuals without congenital or chronic diseases requiring treatment and with no pathological symptoms or findings from internal medical examinations (if necessary, brain waves, electrocardiograms, chest and upper gastrointestinal endoscopy or gastrointestinal radiographic examinations)
Individuals deemed suitable for the clinical trial based on clinical trial laboratory tests, vitality signs, physical examinations, and 12-lead electrocardiogram results conducted according to the characteristics of the investigational product at screening
Individuals with negative H. pylori antibody results at screening
Individuals who have heard a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and agree in writing to comply with the subject compliance requirements during the clinical trial period

Who cannot join

Individuals with a current or past medical history of clinically significant conditions affecting the liver, kidneys, nervous system, psychiatric system, respiratory system, endocrine system, hematologic disorders, tumors, genitourinary system, cardiovascular system, digestive system, musculoskeletal system, or any of the following current or past conditions:
Renal impairment
Hepatic impairment
Individuals with a history of gastrointestinal disorders (such as Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of investigational drugs
Women who are pregnant (as indicated by positive Urine-HCG) or lactating
Individuals with a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or clinically significant hypersensitivity reactions to drugs containing Ilaprazole, excipients (Tartrazine, Sunset Yellow FCF), or other drugs (such as aspirin, penicillin antibiotics, macrolide antibiotics)

Show all 26Show fewer

Individuals with clinically significant findings, including the following, on the 12-lead electrocardiogram performed at screening:
QTc > 450 ms for males or QTc > 470 ms for females
PR interval > 200 ms
QRS duration > 120 ms
Individuals with clinically significant results, including the following, on clinical trial laboratory tests performed at screening:
AST, ALT, ALP, γ-GT, and total bilirubin levels exceeding twice the upper limit of the normal range for liver function evaluation
Serum creatinine levels outside the reference range or estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula < 60 mL/min/1.73m2
Individuals with a history of drug abuse or positive urine drug test results for abused drugs
Individuals with systolic blood pressure ≥ 150 mmHg or ≤ 90 mmHg, or diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg, or heart rate ≤ 40 bpm or ≥ 100 bpm upon measurement in the supine position after resting for more than 3 minutes at screening
Individuals with abnormal diets that may affect the absorption, distribution, metabolism, and excretion of investigational drugs or affect drug metabolism
Individuals who have taken any prescription drugs or herbal medicines that may affect the characteristics of investigational drugs within 2 weeks prior to the first dosing day or any over-the-counter drugs or vitamin supplements within 10 days prior to the first dosing day (however, participation in the clinical trial may be allowed based on the participant's judgment if the drug does not affect the pharmacokinetic properties of the investigational drug)
Individuals who have been administered inducers or inhibitors of drug metabolism, such as barbiturates, within 1 month prior to the first dosing day
Individuals who have participated in another clinical trial and received treatment within 6 months prior to the first dosing day (however, the end date of participation in another clinical trial is calculated as 1 day after the last dosing day)
Individuals who have donated whole blood within 2 months or component blood within 1 month prior to the first dosing day, received blood transfusions within 1 month, or cannot abstain from blood donation from the time of written consent until PSV
Individuals who have consumed alcohol excessively (more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the first dosing day or cannot abstain from the time of written consent until PSV
Individuals who have consumed grapefruit-containing foods from 48 hours before the first dosing to PSV or cannot abstain from consumption
Individuals who have engaged in vigorous exercise exceeding their usual daily activities from 48 hours before the first dosing to PSV or cannot abstain from such exercise
Individuals who, from the time of written consent until 2 weeks after the last dosing day based on the date of the last administration of investigational drugs, are not using or planning to use recognized contraceptive methods for planning or not planning pregnancy (e.g., contraceptive pills and implants, intrauterine devices, infertility procedures (vasectomy, tubal ligation), barrier methods (combined use of spermicides with condoms, vaginal sponges, cervical caps))
Individuals for whom insertion and maintenance of a pH meter catheter for gastric pH measurement is difficult
Individuals who are deemed unsuitable for participation in the clinical trial by the investigator for reasons other than the selection/exclusion criteria mentioned above.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chungbuk National University Hospital
Seoul, Seowon-gu, 28644

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, PK and PD Characteristics After Oral Administration of IY-NS250 and IY-NT-SR in Healthy Adult Volunteers

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

Read the detailed description

Not provided

Conditions: Pharmacokinetics, Pharmacodynamics
Being tested: IY-NS250, IY-NT-SR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IY-NS250Drug
Ilaprazole 20mg + Sodium bicarbonate 500mg
IY-NT-SRDrug
Also called Noltec(the brand name)
Ilaprazole 10mg

Study groups in NCT06725992
Study group	Role	What they receive
A group	Active comparator	Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : IY-NS250 1Tab, one a day Receives: Drug: IY-NS250; Drug: IY-NT-SR
B group	Active comparator	Period 1 : IY-NS250 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day Receives: Drug: IY-NS250; Drug: IY-NT-SR

What is being measured

The primary outcome is the main question the study is designed to answer.

Ilaprazole AUCτ,ss
Ilaprazole AUCτ,ss
Measured: 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
Measured: Day -1 -24hour ~ 0h Day7 Predose(0hour) ~ 24hour

Secondary outcomes (18)

AUCinf,ss
AUCinf,ss, of Ilaprazole after repeated administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Tmax,ss
Tmax,ss of Ilaprazole after repeated administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202414 Aug 2024

First posted10 Dec 2024
Study start30 Jan 2024
Primary completion13 Apr 2024
Study completion14 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: A randomized, open-label, multiple-dose, crossover phase 1 clinical trial
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06725992
Sponsor's protocol ID: IY-NS250SB
Status last verified: Dec 2024
First submitted: 21 Feb 2024
Last updated: 10 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, PK and PD Characteristics After Oral Administration of IY-NS250 and IY-NT-SR in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT06725992
Acronym / sponsor ID: IY-NS250SB
Conditions: Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jan 2024 (actual)
Primary completion: 13 Apr 2024 (actual)
Study completion: 14 Aug 2024 (actual)
First posted: 10 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Not provided

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: A randomized, open-label, multiple-dose, crossover phase 1 clinical trial

Arm	Type	Receives
A group	Active comparator	Drug: IY-NS250, Drug: IY-NT-SRPeriod 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : IY-NS250 1Tab, one a day
B group	Active comparator	Drug: IY-NS250, Drug: IY-NT-SRPeriod 1 : IY-NS250 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy adult volunteers aged 19 years or older at screening
Individuals with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 at screening
ndividuals without congenital or chronic diseases requiring treatment and with no pathological symptoms or findings from internal medical examinations (if necessary, brain waves, electrocardiograms, chest and upper gastrointestinal endoscopy or gastrointestinal radiographic examinations)
Individuals deemed suitable for the clinical trial based on clinical trial laboratory tests, vitality signs, physical examinations, and 12-lead electrocardiogram results conducted according to the characteristics of the investigational product at screening
Individuals with negative H. pylori antibody results at screening

Key exclusion criteria (26 listed)

Individuals with a current or past medical history of clinically significant conditions affecting the liver, kidneys, nervous system, psychiatric system, respiratory system, endocrine system, hematologic disorders, tumors, genitourinary system, cardiovascular system, digestive system, musculoskeletal system, or any of the following current or past conditions:
Individuals with a history of gastrointestinal disorders (such as Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of investigational drugs
Women who are pregnant (as indicated by positive Urine-HCG) or lactating
Individuals with a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or clinically significant hypersensitivity reactions to drugs containing Ilaprazole, excipients (Tartrazine, Sunset Yellow FCF), or other drugs (such as aspirin, penicillin antibiotics, macrolide antibiotics)
Individuals with clinically significant findings, including the following, on the 12-lead electrocardiogram performed at screening:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IY-NS250Ilaprazole 20mg + Sodium bicarbonate 500mg	Drug	A group, B group
IY-NT-SRAlso: Noltec(the brand name)Ilaprazole 10mg	Drug	A group, B group

Primary outcome

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
Ilaprazole AUCτ,ss
integrated gastric acidity
Time frame: Day -1 -24hour ~ 0h Day7 Predose(0hour) ~ 24hour
Percentage decrease in integrated gastric acidity over 24 hours from Day -1 to Day 7

18 secondary outcomes

AUCinf,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
Cmax,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
Cmin,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
Cav,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
Tmax,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
t1/2,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
CLss/F
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)
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)
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
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
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
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
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
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
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
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
Time frame: Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour
nocturnal acid breakthrough (NAB)
Time frame: Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Min Kyu Park, MD, PhD principal investigator

Chungbuk National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IY-NS250 and IY-NT-SR in people with Pharmacokinetics and Pharmacodynamics, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06725992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.