A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose of HEC74647 and HEC110114 on the Pharmacokinetics of Midazolam, and Their Metabolites in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)
研究概览
简要总结
This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4 substrate）in healthy subjects
详细描述
This is a single center, open-label study in healthy adult subjects. Total 14 subjects will be enrolled into the study and will be receive study drug per the defined treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •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.
- •Must be male or female between 18 to 45 years of age inclusive.
- •Male and female should weigh no less than 50 kg and 45 kg respectively, 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
Midazolam Syrup HEC74647PA HEC110114
Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9.
干预措施: Midazolam Syrup (Drug)
Midazolam Syrup HEC74647PA HEC110114
Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9.
干预措施: HEC74647PA (Drug)
Midazolam Syrup HEC74647PA HEC110114
Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9.
干预措施: HEC110114 (Drug)
结局指标
主要结局
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)
时间窗: Day 1, Day9
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-∞)
时间窗: Day 1, Day9
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)
时间窗: Day 1, Day9
Incidence of adverse eventsECG, or Physical Examination.
时间窗: Day 1 to Day16
次要结局
未报告次要终点