NCT07639905尚未招募1 期
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
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年6月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
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
- •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.
排除标准
- •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.
研究组 & 干预措施
HRS-2189 of new process
Experimental
HRS-2189 of new process.
干预措施: HRS-2189 Tablet (Drug)
HRS-2189 of old process
Experimental
HRS-2189 of old process.
干预措施: HRS-2189 Tablet (Drug)
研究者
研究点 (1)
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