A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
- Registration Number
- NCT01970072
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Inclusion Criteria
- Healthy males or females
- Weight range 50 to 100 kg inclusive
- Body mass index (BMI) 18 to 26 kg/m2
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight 9.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight 6.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight 4.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight 1.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight 3.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight 10.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight 2.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight 7.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight 5.Remimazolam Tosylate Remimazolam Tosylate Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight 11.Midazolam Midazolam Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight
- Primary Outcome Measures
Name Time Method To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis Pre-dose to 8 hours post-dosee Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test Pre-dose to 24 hours post-dose Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments Pre-dose to 2 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China