NCT07768111尚未招募1 期
A Single-Center, Open, Fixed-Sequence Clinical Drug Interaction Study Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetic Profile of Flonoltinib Maleate Tablets in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets.
This trial includes screening period, baseline period, medication observation period, and follow-up period, totaling approximately 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Chinese healthy adult , aged 18-45 years old
- •During the screening period, participants male weight >=50.0 kg, female weight >=45.0 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
- •Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
排除标准
- •Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
- •HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
- •Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
- •Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in
- •Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection
研究组 & 干预措施
Part A
Experimental
干预措施: 75mg Flonoltinib (Drug)
Part B
Experimental
干预措施: 100mg Flonoltinib (Drug)
结局指标
主要结局
Cmax
时间窗: Until 144hours
Tmax
时间窗: Until 144hours
AUC0-t
时间窗: Until 144hours
t1/2
时间窗: Until 144hours
次要结局
- Safety and Tolerability(From dosing (Day 0) through study completion (Day 29))
研究者
研究点 (1)
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