A Phase I, Open-label, 2-sequence, Cross-over, Pharmacokinetic (PK) Study to Evaluate the Effect of the Food and to Identify the Metabolism of Fluzoparib in Healthy Subjects
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
- Pharmacokinetics - Cmax
研究概览
简要总结
This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give written informed consent.
- •Must be willing to comply with the requirements of the study.
- •Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months.
- •Male or female aged 18-50 years.
- •Weight more than 45kg, BMI within 18 and 28 kg/m
- •No clinically significant abnormalities in physical examination and lab tests.
排除标准
- •Pregnant or breast-feeding women.
- •No history of alcohol or drug abuse within the past year.
- •Participation in any clinical trial of an experimental drug or device in the previous 3 months.
- •Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
研究组 & 干预措施
Group A
Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2
干预措施: Fluzoparib (Drug)
Group B
Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2
干预措施: Fluzoparib (Drug)
结局指标
主要结局
Pharmacokinetics - Cmax
时间窗: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Peak Plasma Concentration (Cmax) and the the 90% confidence interval were calculated.
Pharmacokinetics-AUC
时间窗: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Area under the plasma concentration versus time curve (AUC0-last，AUC0-infinity) and the 90% confidence intervals were calculated.
Pharmacokinetics - Tmax (Hours)
时间窗: pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals.
Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC
时间窗: 0-96h post dose if availabel
This study was also designed to clarify the metabolism of Fluzoparib 120mg.
次要结局
未报告次要终点