A Phase Ⅰb Study Evaluating the Pharmacokinetic,Safety and Efficacy of Remimazolam Tosylate in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of Remimazolam in human plasma.
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
详细描述
- Study the Pharmacokinetics/Pharmacodynamics of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
- Study the reversal effect and time required of Flumazepine on Rimazolam'effect.
- Study the Safety of Remimazolam Tosylate in healthy volunteers after loading/maintenance dose regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Aged ≥18 and ≤55 years.
- •Weight range 50 to 100 kg and body mass index (BMI) 18 to 26 kg/m
- •Willing and able to comply with the requirements of the protocol.
- •Provide written informed consent to participate in the study.
排除标准
- •Abnormal results of physical or laboratory examination with clinical significance
- •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).
- •With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor.
- •Subject with clinically significant abnormalities in baseline 12-lead electrocardiogram (ECG) or vital signs（SBP <90 mmHg or >140 mmHg，DBP <50 mmHg or >90 mmHg；Hr <50 bpm or >100 bpm；SpO2 <95%）.
- •Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated.
- •Receipt of other medication within 14 days of the first study day.
- •Blood donation greater than 200 ml or participation in a clinical study of an unlicensed drug in the previous 3 months.
- •History of smoking or alcohol abuse within 6 months of screening.
- •History of grapefruit juice or any other foods affect the activity of cytochrome P450 3A4（CYP3A4） within 7 days of screening.
- •Pregnant,lactating.
- •Mallampati score ≥
- •Patients who in the opinion of the investigator may not be able to comply with the requirements of the study are not eligible
研究组 & 干预措施
Remimazolam Tosylate 1
IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start， 0.5 mg Flumazenil is administered
干预措施: Remimazolam Tosylate (Drug)
Remimazolam Tosylate 2
IV bolus of Remimazolam Tosylate with a loading dose of 0.4mg/kg body weight over 1 minute followed by a maintenance dose of 1.5mg/kg/h over 2 hours.1 h 55 min after dosing start time,0.5ml placebo is administered
干预措施: Remimazolam Tosylate (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of Remimazolam in human plasma.
时间窗: From prior to study drug injection until 4 hours post-dose
Peak Plasma Concentration (Cmax) of M01 in human plasma.
时间窗: From prior to study drug injection until 4 hours post-dose
M01 is the main metabolite of Remimazolam
Area under the plasma concentration versus time curve (AUC) of M01 in human plasma.
时间窗: From prior to study drug injection until 4 hours post-dose
M01 is the main metabolite of Remimazolam
Peak Plasma Concentration (Cmax) of Remimazolam in human plasma.
时间窗: From prior to study drug injection until 4 hours post-dose
次要结局
- Safety by measurement of Adverse Events.(From start of study drug injection to patient discharge (approx. 2 days))