A Single-center, Non-randomized, Open-label, Self-controlled Phase I Drug-drug Interaction Clinical Study to Evaluate the Pharmacokinetics of JMKX003142 With Amiodarone, and Febuxostat in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Cmax，ss
研究概览
简要总结
This is a open-label, non-randomized, multiple oral dosings, three-period, drug-drug interaction study of JMKX003142 tablet, Amiodarone Hydrochloride Tablets and Febuxostat Tablets in Chinese healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 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
- •Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form. Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
- •The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
- •Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm/egg for the time period specified above.
排除标准
- •Subjects having hypersensitivity to study drug or have a history of allergies to multiple drugs, foods, or other substances
- •History or presence of significant circulatory system, respiratory system, digestive system, blood system, urinary and reproductive system, endocrine and metabolic system, nervous system, mental system, muscular and skeletal system, skin system, lymphatic system, immune system, Otolaryngology or other related systems disease or disorder. as well as systemic or local acute or chronic infections.
- •Subjects with dysphagia, gastrointestinal diseases, or any conditions that may affect drug absorption; such as a history of hepatobiliary and pancreatic diseases, gastrointestinal diseases, gastrointestinal surgery (except appendectomy), or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
- •Vital signs during the screening period meet any of the following conditions: systolic blood pressure >140 mmHg or <90 mmHg; diastolic blood pressure >90 mmHg or <50 mmHg (Cohort 1: diastolic blood pressure >90 mmHg or <60 mmHg); pulse >100 beats/min or <50 beats/min (Cohort 1: pulse >100 beats/min or <60 beats/min); ear temperature >37.5°C or <35°C.
- •History of QTc interval prolongation or abnormal ECG results during screening, QTcF ≥ 450 ms for males or ≥ 470 ms for females, or QRS interval > 120 ms.
研究组 & 干预措施
Drug-Drug interaction study of JMKX003142 and Amiodarone
24 Subjects first administered with JMKX003142 tablets 4mg from day 1 to day 7 after breakfast. from day 12 to day 18 the subjects were adminstered with Amiodarone Hydrochloride Tablets 400 mg. from day 22 to day 28 these subjects were co-adminstered with JMKX003142 tablets 4mg and Amiodarone Hydrochloride Tablets 400 mg.
干预措施: Amiodarone Hydrochloride Tablets (Drug)
Drug-Drug interaction study of JMKX003142 with Febuxostat
24 Subjects first administered with JMKX003142 tablets 4mg from day 1 to day 7 after breakfast. from day 12 to day 18 the subjects were adminstered with Febuxostat Tablets 40 mg. from day 21 to day 27 these subjects were co-adminstered with JMKX003142 tablets 4mg and Febuxostat Tablets 40 mg.
干预措施: Febuxostat Tablets (Drug)
结局指标
主要结局
Cmax，ss
时间窗: up to 7 days
AUC0-tau
时间窗: up tp 7 days
次要结局
- Tmax(up to 7 days)
- AUC0-t(up to 7 days)