Effect of Rifampicin on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
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 (AUC) of Apatinib
研究概览
简要总结
The primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with rifampicin. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with rifampicin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •female of non-childbearing potential or male;
- •age 18-45 years;
- •body mass index 19-24 kg/m2 with total body weight;
排除标准
- •clinically significant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs;
- •history of alcohol abuse; smoker;
- •electrocardiogram(ECG) abnormality;
- •blood pressure >140/90 mmHg;
- •treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication;
- •Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.
研究组 & 干预措施
Apatinib
subjects receiving a single 750 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then rifampicin capsules 600 mg/day orally for 10 days with a single 750 mg oral dose of apatinib mesylate tablets co-administered on day 8 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h
干预措施: Apatinib Mesylate Tablets (Drug)
Apatinib
subjects receiving a single 750 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then rifampicin capsules 600 mg/day orally for 10 days with a single 750 mg oral dose of apatinib mesylate tablets co-administered on day 8 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h
干预措施: Rifampicin Capsules (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Apatinib
时间窗: 0~72h after apatinib administration
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(From first administration to the seventh day after last administration)
- Peak Plasma Concentration (Cmax) of Apatinib(0~72h after apatinib administration)