A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy Volunteers aged between 18 and 45 years old;
- •Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);
- •The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;
排除标准
- •The participant were deemed unsuitable for participating in the study by the investigator for any reason.
研究组 & 干预措施
Inhibitor group
Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Inhibitor group
Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.
干预措施: Itraconazole capsule (Drug)
Inducer group
- Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day.
- Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Inducer group
- Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day.
- Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.
干预措施: Rifampicin Capsules (Drug)
结局指标
主要结局
Cmax
时间窗: Up to 32 Days
Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration
AUC
时间窗: Up to 32 Days
Area under the plasma concentration versus time curve (AUC) of Jaktinib
Adverse Events
时间窗: Up to 32 Days
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
次要结局
未报告次要终点