A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244
研究概览
简要总结
To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •18≤ age ≤ 45, male or female;
- •Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m^2 (inclusive);
- •Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
- •The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.
排除标准
- •Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
- •Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
- •Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
- •With positive alcohol breath test;
- •Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
研究组 & 干预措施
Test Group
Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Reference Group
Subjects in the first sequence of the first cycle were administered with a test formulation (T) of 50 mg of Jaktinib on an empty stomach, while subjects in the second sequence were administered with a reference formulation (R) of 50 mg of Jaktinib on an empty stomach. The reference formulation (R) or test formulation (T) was administered alternately in the next periods.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244
时间窗: up to 48 hours
Maximum Plasma Concentration (Cmax)
Jaktinib and its main metabolite ZG0244 AUC(0-inf)
时间窗: up to 48 hours
Area under the concentration time curve from time 0 to infinity
Jaktinib and its main metabolite ZG0244 AUC(0-t)
时间窗: up to 48 hours
Area under the concentration time curve from time 0 to time of the last quantifiable
次要结局
- Adverse events(Day 1 to Day 12)
- Jaktinib and its main metabolite ZG0244 t1/2(up to 48 hours)
- Jaktinib and its main metabolite ZG0244 Tmax(up to 48 hours)