A Placebo-Controlled, Phase I, Single-center Evaluation of the Single-dose Pharmacokinetics Study of Azilsartan Trimethylethanolamine
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy males or females
- •Aged from 18 years to 45 years
- •Body mass index (BMI) 19 to 25kg/m2
排除标准
- •Has a known sensitivity to angiotensin II receptor blocker（ARB）
- •With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor
- •Has known or suspected history of alcoholism or drug abuse or misuse
- •With a history of laboratory results that show the presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV)
- •Pregnant,lactating，menstrual
- •Vegetarian
- •Postural hypotension
- •Systolic blood pressure<100mmHg，or>130mmHg;and/or diastolic blood pressure<70mmHg,or>90mmHg
研究组 & 干预措施
1.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
2.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
3.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 35mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
4.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 70mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
5.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 140mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
6.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 210mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
7.Azilsartan Trimethylethanolamine
Single dose of Azilsartan Trimethylethanolamine with 280mg,orally
干预措施: Azilsartan Trimethylethanolamine (Drug)
Placebo
Placebo-matching tablets, orally
干预措施: Placebo (Drug)
结局指标
主要结局
To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis
时间窗: Pre-dose to 72 hours post-dosee
Number of participants with adverse reactions
时间窗: Pre-dose to 72 hours post-dose
The trial shoud be terminated ，if more than a third of participants had grade 2 or more than 2 adverse reactions based on Common Terminology Criteria for Adverse Events(CTCAE) Version 4.02
次要结局
未报告次要终点