A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
详细描述
This is a 2-part study with each part is an open-label study in healthy adult subjects.
Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1~7 and Day 13~19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
- •Be able to complete the study according to the trail protocol.
- •Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
- •Male subjects and must be 18 to 45 years of age inclusive.
- •Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
- •Physical examination and vital signs without clinically significant abnormalities.
排除标准
- •Use of >5 cigarettes per day during the past 3 months.
- •Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
- •History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
- •Donation or loss of blood over 450 mL within 3 months prior to screening.
- •12-lead ECG with clinically significant.
- •Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
Part A
Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19.
干预措施: HEC74647 (Drug)
Part A
Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19.
干预措施: HEC110114 (Drug)
Part B
Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19.
干预措施: HEC74647 (Drug)
Part B
Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19.
干预措施: HEC110114 (Drug)
结局指标
主要结局
Adverse Events
时间窗: From Days 1-26
Incidence of adverse events
AUC
时间窗: Day 7-12 and Day 19-26
Maximum plasma concentration of study drugs
Cmax
时间窗: Day 7-12 and Day 19-26
Maximum plasma concentration of study drugs
次要结局
未报告次要终点