NCT06725992
Completed
Phase 1
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
Il-Yang Pharm. Co., Ltd.1 site in 1 country56 target enrollmentJanuary 30, 2024
Overview
- Phase
- Phase 1
- Intervention
- IY-NS250
- Conditions
- Pharmacokinetics
- Sponsor
- Il-Yang Pharm. Co., Ltd.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Ilaprazole AUCτ,ss
- Status
- Completed
- Last Updated
- last year
Overview
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
Detailed Description
Not provided
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
A group
Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : IY-NS250 1Tab, one a day
Intervention: IY-NS250
A group
Period 1 : Ilaprazole 10mg 2Tab, one a day Period 2 : IY-NS250 1Tab, one a day
Intervention: IY-NT-SR
B group
Period 1 : IY-NS250 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day
Intervention: IY-NS250
B group
Period 1 : IY-NS250 1Tab, one a day Period 2 : Ilaprazole 10mg 2Tab, one a day
Intervention: IY-NT-SR
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- t1/2,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)
- CLss/F(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)(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)(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(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(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(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(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(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(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(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(Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour)
- nocturnal acid breakthrough (NAB)(Day -1 -24hour ~ 0h Day 1 Predose(0hour) ~ 24h Day7 Predose(0hour) ~ 24hour)
Study Sites (1)
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