NCT00920998已完成1 期
A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacokinetics of Z-338
研究概览
简要总结
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.
详细描述
The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subject
- •Body weight: 50.0 - 80.0 kg
- •BMI: 17.6 - 26.4
排除标准
- •Receiving an investigational new drug within 120 days of the study
- •Receiving medical treatment drugs within 7 days of the study
- •Blood donation before the study
研究组 & 干预措施
1. Z-338
Experimental
3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions)
干预措施: Z-338 (Drug)
结局指标
主要结局
Pharmacokinetics of Z-338
时间窗: 48 hours
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328HealthyNCT00752830AstraZeneca14
已完成
1 期
A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent FormulationOsteoporosis, PostmenopausalBone DiseasesOsteoporosisNCT00965978Astellas Pharma Inc48
已完成
3 期
A Phase III Trial of Z-338 in Paediatric Patients With Functional DyspepsiaFunctional DyspepsiaNCT04526119Zeria Pharmaceutical55
已完成
1 期
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid MalignanciesMalignant MelanomaMelanomaNCT00710515AstraZeneca30
已完成
1 期
A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941HealthyPharmacokinetics of ASP1941NCT01674777Astellas Pharma Inc30