A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- To study the Pharmacokinetics of Remimazolam Tosylate 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 and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females
- •Weight range 50 to 100 kg inclusive
- •Body mass index (BMI) 18 to 26 kg/m2
排除标准
- •Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated
- •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 within 6 months of Screening or evidence of tolerance or physical dependence before dosing with study drug
- •With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)
- •Pregnant,lactating
- •Mallampati score ≥3
研究组 & 干预措施
11.Midazolam
Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight
干预措施: Midazolam (Drug)
1.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
2.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
3.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
4.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
5.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
6.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
7.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
8.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
9.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
10.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight
干预措施: Remimazolam Tosylate (Drug)
结局指标
主要结局
To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
时间窗: Pre-dose to 8 hours post-dosee
Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test
时间窗: Pre-dose to 24 hours post-dose
Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments
时间窗: Pre-dose to 2 hours post-dose
次要结局
未报告次要终点