A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-06-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Midazolam

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