A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-14

Study Completion Date

2014-06-20

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.01 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

2.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.02 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

3.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.05 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

4.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.075 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

5.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.1 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

6.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.15 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

7.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.2 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

8.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.25 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

9.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.3mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

10.Remimazolam Tosylate

Single IV bolus of Remimazolam Tosylate over 1 minute at 0.35 mg/kg body weight

Group Type EXPERIMENTAL

Remimazolam Tosylate

Intervention Type DRUG

11.Midazolam

Single IV bolus of Midazolam over 1 minute at 0.075 mg/kg body weight

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Interventions

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Remimazolam Tosylate

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes