The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
研究概览
简要总结
The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy male 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
- •Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results(clinical laboratory test, 12-lead GCG etc)
排除标准
- •Subject who is hypersensitive to components contained in YH4808 or this drug
- •Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
- •Subject who has history of surgical operation or diseases related to gastrointestinal symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
- •Other exclusions apply
研究组 & 干预措施
YH4808, amoxicillin, clarithromycin
single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
干预措施: YH4808 (Drug)
YH4808, amoxicillin, clarithromycin
single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
干预措施: Amoxicillin (Drug)
YH4808, amoxicillin, clarithromycin
single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
干预措施: clarithromycin (Drug)
YH4808, amoxicillin and clarithromycin
7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
干预措施: YH4808 (Drug)
YH4808, amoxicillin and clarithromycin
7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
干预措施: Amoxicillin (Drug)
nexium, amoxicillin and clarithromycin
BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
干预措施: Amoxicillin (Drug)
YH4808, amoxicillin and clarithromycin
7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
干预措施: clarithromycin (Drug)
YH4808 and amoxicillin
7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
干预措施: YH4808 (Drug)
YH4808 and amoxicillin
7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
干预措施: Amoxicillin (Drug)
nexium, amoxicillin and clarithromycin
BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
干预措施: Nexium (Drug)
nexium, amoxicillin and clarithromycin
BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
干预措施: clarithromycin (Drug)
结局指标
主要结局
Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin
时间窗: pre dose, 16 times after dosing
次要结局
- Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin(pre dose, 16 times after dosing)