A Randomized, Open-label, Multiple-dose, Partial Crossover Study to Explore the Pharmacokinetics and the Pharmacodynamics of YH4808 New Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The AUC0-24h of YH4808
研究概览
简要总结
The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adult age 20 to 55 over 55kg with ideal body weight(BMI) 18.5 ~ 25
- •Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- •negative to Helicobacter pylori in 13C urea breath test
- •Subject who judged to be eligible according to various test results including laboratory test(serum test, hematologic/blood chemistry examination, urine test, etc.) and 12-lead ECG test performed within 4 weeks before the first IP administration.
- •Subject who agreed to maintain contraception and comply with medically verified contraception methods (including infertility)
排除标准
- •Subject who has history or presence of clinically significant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, reproductive, musculoskeletal system, mental disorder, ophthalmologic disease, and skin disease in investigator's judgement.
- •Subject who has history of surgical operation or disease related to gastrointestinal symptoms (e.g. crohn's diseas, ulcer, etc. except for appendectomy or simple hernia) which could have influence on the absorption of IP.
- •Subject who is hypersensitive to components contained in YH4808 and other drugs(aspirin, antibiotics, etc.)
- •pregnant or lactating woman.
- •Other exclusions apply.
研究组 & 干预措施
Cohort2-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg before meal
干预措施: YH4808 NF 100 (Drug)
Cohort1-YH4808 NF 100
7 days repeat administration of YH4808 New Formulation 100mg after meal
干预措施: YH4808 NF 100 (Drug)
Cohort1-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal
干预措施: YH4808 OF 200 (Drug)
Cohort1-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal
干预措施: YH4808 NF 200 (Drug)
Cohort1-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal
干预措施: YH4808 OF 200 (Drug)
Cohort1-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal
干预措施: YH4808 NF 200 (Drug)
Cohort1-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg after meal
干预措施: YH4808 NF 400 (Drug)
Cohort2-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
干预措施: YH4808 OF 200 (Drug)
Cohort2-YH4808 NF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
干预措施: YH4808 NF 200 (Drug)
Cohort2-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
干预措施: YH4808 OF 200 (Drug)
Cohort2-YH4808 OF 200
(Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal
干预措施: YH4808 NF 200 (Drug)
Cohort2-YH4808 NF 400
7 days repeat administration of YH4808 New Formulation 400mg before meal
干预措施: YH4808 NF 400 (Drug)
Cohort3-YH4808 OF 200
(Partial cross over design)
- 7 days repeat administration of YH4808 Old Formulation 200mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before dinner
- 7 days repeat administration of YH4808 Old Formulation 200mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before bed
干预措施: YH4808 OF 200 (Drug)
Cohort3-YH4808 OF 400
(Partial cross over design)
- 7 days repeat administration of YH4808 Old Formulation 400mg before bed, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before dinner
- 7 days repeat administration of YH4808 Old Formulation 400mg before dinner, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 400mg before bed
干预措施: YH4808 OF 200 (Drug)
结局指标
主要结局
The AUC0-24h of YH4808
时间窗: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The AUC0-24h of M3
时间窗: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The Cmax of M3
时间窗: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
The Cmax of YH4808
时间窗: Day 1(Day 35), Day 7(Day 41)
Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing
次要结局
- The Duration of stomach maintained over pH4 or 5(Day 1(Day7)~Day2(Day8))
- the arithmetic mean of 24h intragastric pH monitoring(Day 1(Day7)~Day2(Day8))
- the median of 24h intragastric pH monitoring(Day 1(Day7)~Day2(Day8))