Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetics parameter AUC0-t of HLX208
研究概览
简要总结
This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.
Part II is the drug-drug interaction study, an open-label and sequential design. 32 healthy subjects are planned to be enrolled and divided into group A and group B. Group A is to evaluate the influence of itraconazole as CYP3A4 strong inhibitory on HLX208. Group B was to evaluate the effect of rifampicin as a strong inducer of CYP3A4 on HLX208.
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
- •Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements;
- •Male or female subjects aged 18 to 45 (including 18 and 45);
- •Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m
- •BMI = weight (kg)/[height (m)]2;
排除标准
- •Known history of drug or food allergy;
- •Those who have a positive urine drug screen or have a history of drug abuse;
- •Excessive smoking (≥ 5 cigarettes/day);
研究组 & 干预措施
HLX208 in the fed state
HLX208 900mg in the fed state
干预措施: HLX208 (Drug)
HLX208 in the fast state
HLX208 900mg in the fast state
干预措施: HLX208 (Drug)
HLX208 + Itraconazole group
HLX208 + Itraconazole group
干预措施: HLX208 (Drug)
HLX208 + Itraconazole group
HLX208 + Itraconazole group
干预措施: Itraconazole 200 mg (Drug)
HLX208 + rifampicin group
HLX208 + rifampicin group
干预措施: HLX208 (Drug)
HLX208 + rifampicin group
HLX208 + rifampicin group
干预措施: Rifampicin (Drug)
结局指标
主要结局
Pharmacokinetics parameter AUC0-t of HLX208
时间窗: up to 48 hours
AUC0-t of HLX208
Pharmacokinetics parameter Cmax of HLX208
时间窗: up to 48 hours
Cmax of HLX208
Pharmacokinetics parameter AUC0-inf of HLX208
时间窗: up to 48 hours
AUC0-inf of HLX208
次要结局
- other pharmacokinetics parameter Tlag of HLX208(up to 48 hours)
- other pharmacokinetics parameter Tmax of HLX208(up to 48 hours)
- other pharmacokinetics parameter CL/F of HLX208(up to 48 hours)
- other pharmacokinetics parameter Vd/F of HLX208(up to 48 hours)
- other pharmacokinetics parameter t1/2 of HLX208(up to 48 hours)
- other pharmacokinetics parameter MRT of HLX208(up to 48 hours)
- other pharmacokinetics parameter %AUCex of HLX208(up to 48 hours)
- The incidence and severity of adverse events/serious adverse events(up to 17 days after the last dose)