A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Remimazolam Tosylate
Drug: Midazolam
Details and patient eligibility
About
The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers
Enrollment
79 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
79 participants in 11 patient groups
1.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
2.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
3.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
4.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
5.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
6.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
7.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
8.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
9.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
10.Remimazolam Tosylate
Experimental group
Description:
Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight
Treatment:
Drug: Remimazolam Tosylate
11.Midazolam
Active Comparator group
Description:
Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight
Treatment:
Drug: Midazolam
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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