A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets
2026年6月5日 更新者:Shandong Suncadia Medicine Co., Ltd.
A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects
This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.
研究概览
研究类型
介入性
注册 (估计的)
28
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Shaorong Li
- 电话号码:+86-0518-82342973
- 邮箱:shaorong.li@hengrui.com
研究联系人备份
- 姓名:Xingyi Qu
- 电话号码:+86-0518-82342973
- 邮箱:xingyi.qu.xq5@hengrui.com
学习地点
-
-
Anhui
-
Hefei、Anhui、中国、230601
- The Second Affiliated Hospital of Anhui Medical University
-
首席研究员:
- Wei Hu
-
接触:
- Wei Hu
- 电话号码:+86-0551-65997421
- 邮箱:ayefygcp@163.com
-
接触:
- Renpeng Zhou
- 电话号码:+86-0551-65997421
- 邮箱:zhourenpeng@ahmu.edu.cn
-
首席研究员:
- Renpeng Zhou
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
- Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
- Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 [BMI = weight (kg) / height2 (m2)] (including both endpoints).
- Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.
Exclusion Criteria:
- Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
- Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
- Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
- Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
- Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.
- Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result.
- Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result.
- The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study.
- Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
- Pregnant and lactating women.
- Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
- Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:HRS-2189 of new process
HRS-2189 of new process.
|
HRS-2189 tablet, oral.
|
|
实验性的:HRS-2189 of old process
HRS-2189 of old process.
|
HRS-2189 tablet, oral.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The maximum plasma concentration (Cmax)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to maximum plasma concentration (Tmax)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
|
Terminal half-life (t1/2)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
|
Apparent clearance (CL/F)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
|
Apparent volume of distribution (Vz/F)
大体时间:Day1 - Day37.
|
Day1 - Day37.
|
|
|
Incidence and severity of adverse events (AEs)
大体时间:Day1 - Day37.
|
Safety measure.
|
Day1 - Day37.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年7月1日
研究注册日期
首次提交
2026年6月5日
首先提交符合 QC 标准的
2026年6月5日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月5日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- HRS-2189-102
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.