NCT07588646已完成1 期
A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
研究概览
简要总结
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects. A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and nintedanib in healthy male 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
- 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
- •Subjects who are willing and are able to provide a written informed consent to participate in the study.
- •Without Plann for pregnant or sperm/egg donation plan, and voluntary effective contraceptive measures during the trial period and within 3 months after the last dose.
- •Subjects aged between 18 and 45 (both inclusive) years old.
- •The first part of the study included male and female subjects, and the second part of the study included only male subjects.
- •Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
- •Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
排除标准
- •Subjects with a positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies and/or TP antibodies at screening.
- •Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or mental illness.
- •Subjects with photosensitivity and/or other skin diseases.
- •Subjects with Bleeding risk.
- •Subjects with known allergic history or constitution to peanuts, soybeans, study drugs or any of their components.
- •Take any prescription or non-prescription medications within 14 days prior to initial dosing, or take any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- •Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- •Positive results from urine drug screen test.
- •History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- •For the first part of the study, subjects who had positive urine cotinine test or had smoked within 1 month before administration; for the second part of the study, subjects who had smoked more than 10 cigarettes per day within 3 months before administration.
- •Donate blood or lose blood 400 mL or more within 3 months prior to initial dosing.
- •Subjects who plan to receive or have had organ transplants.
- •Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- •Subjects who participated in the other clinical trial within 3 months prior to initial dosing.
- •Others conditions that are not suitable for clinical trial participation.
研究者
研究点 (1)
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