NCT05088655已完成1 期
Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Area Under the plasma concentration vs time curve (AUC0-120)
研究概览
简要总结
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
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
- 否
入选标准
- •Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- •Ability to complete the study as required by the protocol;
- •Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- •Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
排除标准
- •Allergic constitution;
- •History of drug use, or drug abuse screening positive;
- •Alcoholic or often drinkers;
- •History of deep vein thrombosis, or any other thromboembolic event;
- •A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
研究组 & 干预措施
Treatment group A: T - R- R
Experimental
干预措施: Hetrombopag Olamine Tablet (Drug)
Treatment group B: R -T - R
Experimental
干预措施: Hetrombopag Olamine Tablet (Drug)
Treatment group C: R- R-T
Experimental
干预措施: Hetrombopag Olamine Tablet (Drug)
结局指标
主要结局
Area Under the plasma concentration vs time curve (AUC0-120)
时间窗: 0-120 hours post dose
Peak plasma concentration (Cmax)
时间窗: 0-120 hours post dose
area under the plasma concentration vs time curve (AUC0-inf)
时间窗: 0-infinity
次要结局
- Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)(0-120 hours post dose)
- The number of volunteers with adverse events as a measure of safety and tolerability(up to Day 26)
- Half-life Associated With the Terminal Slope (t½)(0-120 hours post dose)
研究者
研究点 (1)
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