An Open-label, Randomised, Single Dose, Cross-over Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is an open-label, randomised, single-dose, cross-over phase I study to evaluate the effect of food on the pharmacokinetic profile of BPI-7711 in Chinese healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged from 18 to 55 years.
- •BMI from 18.5 to 28.0 kg/m2
- •Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance.
排除标准
- •Subjects with clinical significant diseases
- •Subjects with allergic disease history
- •Subjects with gastrointestinal disease history that can affect study drug absorption
- •Subjects with drug abuse history
研究组 & 干预措施
Fasted
BPI-7711 following a period of fasting
干预措施: BPI-7711 (Drug)
High-fat meal
BPI-7711 following a high-fat meal.
干预措施: BPI-7711 (Drug)
结局指标
主要结局
Cmax
时间窗: Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose
Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration
AUC(0-last)
时间窗: Blood samples collected on Day 1 and Day 15 at pre-dose, 1, 2, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144 and 168 hours post BPI-7711 dose
Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint
次要结局
未报告次要终点