跳至主要内容
临床试验/NCT05088655
NCT05088655已完成1 期

Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年6月25日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验