A Randomized, Open, Parallel, Single Center Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3454 Tablets in Healthy Adult Subjects.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年11月最近更新: 2023年11月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 40
试验地点: 1
主要终点: Peak concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the study;
•Able to complete the study according to the requirements of the protocol;
•Subjects aged 18-65 (inclusive);
•Body mass index (BMI) ≥ 18 and ≤ 28 kg/m^2, and male's weight ≥ 50 kg and female's weight ≥ 45 kg;
•Health status: No mental abnormalities, no history of severe neurological, respiratory, digestive, urinary, endocrine, and metabolic abnormalities;
•The subjects have no pregnancy plan, voluntarily take effective contraceptive measures, and no plans to donate sperm or eggs, from the date of signing the inform consent (14 days before signing the inform consent for female subjects) to at least 6 months after the last administration.

排除标准

•Subjects with allergic constitution or a history of allergies to two or more foods or drugs;
•Subjects who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
•Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450 ms for male, QTc ≥ 470 ms for female), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
•Those with multiple factors that affect oral medication (such as inability to swallow, gastrointestinal diseases);
•Have taken any prescription, over-the-counter, vitamin product, or herbal medicine within one month before the first administration;
•Take CYP3A4 inhibitors or inducers within one month before the first administration or before the study medication;
•Those who have taken a special diet (including grapefruit, etc.) or engaged in vigorous exercise within 14 days before the first administration or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
•Abnormal and clinically significant physical examination, vital signs, electrocardiogram, and laboratory tests during the screening period;
•Donated blood or experienced significant blood loss (>450 mL) within 3 months prior to taking the study drug;
•Participated in any clinical trial and took any investigational drug within 3 months prior to taking the study drug;
•Smoke at least 5 cigarettes per day within 3 months prior to the study;
•Positive alcohol breath test or history of alcoholism within 2 weeks prior to screening (drinking 14 units of alcohol per week: 1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine);
•Drug screening positive or those who have used drugs in the past 3 months prior to the study;
•Inability to tolerate venous puncture for blood collection or poor vascular condition;
•The subject is unable to complete the experiment due to personal reasons;
•Other conditions that it is considered not suitable for enrollment assessed by the investigators.

研究组 & 干预措施

TQB3454 tablets under fast condition

Experimental

TQB3454 tablets 600mg, take one dose orally under fast condition.

干预措施: TQB3454 tablets (Drug)

TQB3454 tablets under fed condition

Experimental

TQB3454 tablets 600mg, take one dose orally under fed condition.

干预措施: TQB3454 tablets (Drug)