A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate
Overview
- Phase
- Phase 1
- Intervention
- Midazolam
- Conditions
- Healthy
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
11.Midazolam
Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight
Intervention: Midazolam
1.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight
Intervention: Remimazolam Tosylate
2.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight
Intervention: Remimazolam Tosylate
3.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight
Intervention: Remimazolam Tosylate
4.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight
Intervention: Remimazolam Tosylate
5.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight
Intervention: Remimazolam Tosylate
6.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight
Intervention: Remimazolam Tosylate
7.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight
Intervention: Remimazolam Tosylate
8.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight
Intervention: Remimazolam Tosylate
9.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight
Intervention: Remimazolam Tosylate
10.Remimazolam Tosylate
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight
Intervention: Remimazolam Tosylate
Outcomes
Primary Outcomes
To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis
Time Frame: Pre-dose to 8 hours post-dosee
Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test
Time Frame: Pre-dose to 24 hours post-dose
Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments
Time Frame: Pre-dose to 2 hours post-dose