A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
研究概览
简要总结
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
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
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy adult Japanese male between the age of 20-40
- •body mass index between 18.5-25
排除标准
- •clinically significant abnormal physical examination, vital signs or electrocardiogram
- •use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
- •use of any non-prescription medication within the previous 1 week
- •history of drug or alcohol abuse
研究组 & 干预措施
Rabeprazole sodium Tablets, 5 mg
干预措施: Rabeprazole sodium, 5 mg Tablets (Drug)
Rabeprazole sodium Tablets, 10 mg
干预措施: Rabeprazole sodium, 10 mg Tablets (Drug)
Rabeprazole sodium Tablets, 20 mg
干预措施: Rabeprazole sodium, 20 mg Tablets (Drug)
Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets)
干预措施: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets) (Drug)
结局指标
主要结局
Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
时间窗: Day 5 of administration during Period I-IV
The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
次要结局
- Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)(Day 1 and Day 5 of administration during Period I-IV)
- Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])(Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose))