A Multicenter, Randomized, Open-label, Two-formulation, Two-sequence, Two-period Crossover Study to Evaluate the Bioequivalence of Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2023年3月20日最近更新: 2025年12月16日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
入组人数: 36
试验地点: 1
主要终点: Maximum 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

The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Evaluate the human bioequivalence of single dose Reference Listed Drug (RLD) after meals, providing reference for clinical evaluation and medication use.

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: Triple (Participant, Care Provider, Investigator)

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

•Healthy subjects aged 18 to 65 years, inclusive of both 18 and 65 years old;
•Male subjects with a weight of not less than 50.0 kilograms, and female subjects with a weight of not less than 45.0 kilograms; Body Mass Index (BMI) = weight (kg) / height2 (m2), with a BMI range of 18 to 28 kg/m2, inclusive of the boundary values;
•Subjects willing to abstain from childbearing from 2 weeks prior to screening until 6 months after the last administration of the study medication, and voluntarily adopt effective contraceptive measures, with no plans for sperm or egg donation, and ensure the use of one or more non-pharmaceutical contraceptive methods during sexual activity from 2 weeks prior to screening until 6 months after the last administration of the study medication;
•Subjects must sign an informed consent form before the trial, fully understand the content, process, and potential adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.

排除标准

•Subjects with any clinically significant abnormal clinical manifestations that have occurred or are ongoing and require exclusion, including but not limited to neurological/psychiatric, respiratory, cardiovascular, gastrointestinal (any history of gastrointestinal diseases affecting drug absorption), hematopoietic and lymphatic systems, hepatorenal function, endocrine system, and immune system diseases;
•Subjects with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers, or with any coagulation disorders (such as von Willebrand's disease or hemophilia) or a history of bleeding disorders;
•Subjects with clinically significant abnormalities in physical examination, vital sign measurements, electrocardiogram, and laboratory tests;
•Subjects with clinically significant abnormalities in prothrombin time (PT) and activated partial thromboplastin time (APTT) tests;
•Subjects with abnormal and clinically significant tests for hepatitis B surface antigen, antibodies to hepatitis C virus, antibodies to human immunodeficiency virus, or antibodies to Treponema pallidum;
•Subjects with a history of allergy to eltrombopag or its excipients;
•Subjects who have donated blood or experienced significant blood loss (≥400mL) within three months prior to the trial;
•Subjects with difficulty swallowing tablets;
•Subjects with a history of fainting at the sight of needles or blood, or who cannot tolerate venipuncture;
•Subjects who have taken any medication that alters liver enzyme activity or combined with inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or quinupristin/dalfopristin, within 28 days before the first intake of the study medication;
•Subjects who have taken any prescription or over-the-counter drugs, any vitamin products, or herbal remedies within 28 days before the first intake of the study medication;
•Subjects who have taken the investigational drug or participated in other drug clinical trials and received corresponding study medications within the last three months;
•Subjects with a history of drug abuse within the last six months, or who have used drugs within the last three months, or who test positive for drug abuse screening;
•Subjects with a history of alcohol abuse within the last six months, defined as a weekly alcohol intake exceeding 14 units (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL of wine with 12% alcohol content), or who cannot abstain from alcohol during the trial period;
•Subjects who smoke more than 5 cigarettes per day within the last six months, or who cannot cease using any tobacco products during the trial period;
•Subjects who have consumed any food or drink rich in flavonoids or furanocoumarins, such as grapefruit, pomelo, mango, dragon fruit, grape juice, or orange juice, within 48 hours before administration;
•Subjects who have consumed any food or drink containing caffeine, tea, or xanthine within 48 hours before administration;
•Subjects who have special dietary requirements during the trial period and cannot comply with the provided diet and corresponding regulations;
•Subjects who engage in intense exercise or have significant changes in exercise habits during the trial period;
•Subjects whom the investigator deems unsuitable for enrollment for other reasons.

研究组 & 干预措施

Group 1: single-dose of test formulation+single-dose of reference formulation

Active Comparator

18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation.

干预措施: Group 1: single-dose of test formulation+single-dose of reference formulation (Drug)

Group 2: single-dose of reference formulation+single-dose of test formulation

Active Comparator

18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation.

干预措施: Group 2: single-dose of reference formulation+single-dose of test formulation (Drug)