NCT05440006已完成1 期
Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
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
- 20
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
研究概览
简要总结
The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects over 18 years;
- •Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
- •Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.
排除标准
- •Subjects with evidence of disease or major surgery;
- •History of drug allergy;
- •Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
- •Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
- •Those who have heavy smokers, alcoholics or drug abuse
- •Lactating female subjects or fertile female subjects
- •Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.
研究组 & 干预措施
Fed+ Fasted
Experimental
The first cycle with high-fat meal, the second cycle under fasting.
干预措施: Fuzuloparib (Drug)
Fasted + Fed
Experimental
The first cycle under fasting, the second cycle with high-fat meal.
干预措施: Fuzuloparib (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
时间窗: day 1 to day 10
Maximum Plasma Concentration (Cmax)
时间窗: day 1 to day 10
Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )
时间窗: day 1 to day 10
次要结局
- The incidence and severity of adverse events/serious adverse events(from ICF signing date to approximate day 23)
研究者
研究点 (1)
Loading locations...
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