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

NCT06725992 | Completed Phase 1

• 1 other identifier: IY-NS250SB
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Ilaprazole AUCτ,ss

  Ilaprazole AUCτ,ss

  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

  Day -1 -24hour ~ 0h Day7 Predose(0hour) ~ 24hour

Secondary Outcomes (18)

• AUCinf,ss

  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

  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

  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

  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

  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

Study Arms (2)

A group

ACTIVE COMPARATOR

Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : IY-NS250 1Tab, one a day

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

Drug: IY-NS250; Drug: IY-NT-SR

Interventions

IY-NS250 DRUG

Ilaprazole 20mg + Sodium bicarbonate 500mg

A group; B group

IY-NT-SR DRUG

Ilaprazole 10mg

Also known as: Noltec(the brand name)

A group; B group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Seoul, Seowon-gu, 28644, South Korea

Location

Study Officials

• Min Kyu Park, MD, PhD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, multiple-dose, crossover phase 1 clinical trial

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: December 10, 2024
• Study Start: January 30, 2024
• Primary Completion: April 13, 2024
• Study Completion: August 14, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

KR (1)