A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822
研究概览
简要总结
This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent
- •Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values.
- •Subjects voluntarily signed written informed consent and were able to communicate well with the investigator
排除标准
- •History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;
- •Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;
- •Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose;
- •The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial
研究组 & 干预措施
JAB-21822+Itraconazole
干预措施: JAB-21822 (Drug)
JAB-21822+Itraconazole
干预措施: Itraconazole (Drug)
JAB-21822+ Rifampicin
干预措施: JAB-21822 (Drug)
JAB-21822+ Rifampicin
干预措施: Rifampicin (Drug)
JAB-21822+ Omeprazole
干预措施: JAB-21822 (Drug)
JAB-21822+ Omeprazole
干预措施: Omeprazole (Drug)
Dazolam , Rosuvastatin calcium and digoxin with JAB-21822
干预措施: JAB-21822 (Drug)
Dazolam , Rosuvastatin calcium and digoxin with JAB-21822
干预措施: Midazolam , Rosuvastatin calcium and digoxin (Drug)
结局指标
主要结局
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822
时间窗: approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822
时间窗: approximately 10 days
Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin
时间窗: approximately 10 days
Observed maximum concentrations (Cmax )of JAB-21822
时间窗: approximately 10 days
Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin
时间窗: approximately 10 days
Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin
时间窗: approximately 10 days
次要结局
未报告次要终点