NCT05509543已完成1 期
Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T in Healthy Adult Volunteers Under Fasting Conditions
Il-Yang Pharm. Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ilaprazole Cmax
研究概览
简要总结
This study evaluate the pharmacokinetic and safety of IY-NT-T in healthy adults
详细描述
Phase 1 study to evaluate the safety and the pharmacokinetics of IY-NT-T in healthy adult volunteers under fasting conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
In order to prevent distortion (bias) affecting test results during sample analysis, this clinical trial shall not be disclosed to analysis manager and analyst until the specimen analysis is completed.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers aged 19 years and above at screening
- •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]
- •A volunteer who has no congenital or chronic diseases, no pathological symptoms, or findings from medical examination at screening
- •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
- •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
- •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
排除标准
- •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
- •A volunteer who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
- •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)
- •A volunteer who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the study drug
- •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.
- •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.
- •A volunteer that meets any of the following categories
- •Volunteer who is hypersensitive to the active ingredient or other ingredients of this drug
- •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
- •A volunteer who is considered by the investigator to be ineligible to participate in this study for other reasons
- •Pregnant or nursing women
研究组 & 干预措施
A group
Active Comparator
Period 1 : Ilaprazole 10mg 2Tab, one a day
Period 2 : Ilaprazole 20mg 1Tab, one a day
干预措施: IY-NT-T (Drug)
A group
Active Comparator
Period 1 : Ilaprazole 10mg 2Tab, one a day
Period 2 : Ilaprazole 20mg 1Tab, one a day
干预措施: IY-NT-R (Drug)
B group
Active Comparator
Period 1 : Ilaprazole 20mg 1Tab, one a day
Period 2 : Ilaprazole 10mg 2Tab, one a day
干预措施: IY-NT-T (Drug)
B group
Active Comparator
Period 1 : Ilaprazole 20mg 1Tab, one a day
Period 2 : Ilaprazole 10mg 2Tab, one a day
干预措施: IY-NT-R (Drug)
结局指标
主要结局
Ilaprazole Cmax
时间窗: 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(Maximum concentration of drug in plasma)
Ilaprazole AUCt
时间窗: 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 AUCt(Area under the concentration-time curve)
次要结局
- Ilaprazole AUC∞(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(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(Predose(0hour), after dose 0.5hour, 1hour, 1.5hours, 2hours, 2.5hours, 3hours, 3.5hours, 4hours, 4.5hours, 5hours, 6hours, 8hours, 10hours, 12hours, 24hours)
研究者
研究点 (1)
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