A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

A Placebo- and Midazolam-Controlled, Phase Ia, Single Ascending-Dose Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Remimazolam Tosylate

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01970072

Enrollment

Registered

2013-10-25

Start date

2013-10-14

Completion date

2014-06-20

Last updated

2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Remimazolam Tosylate, Phase Ⅰ study, Health

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

Interventions

DRUGRemimazolam Tosylate

DRUGMidazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To study the Pharmacokinetics of Remimazolam Tosylate by assessment of drug concentration through blood sample analysis	Pre-dose to 8 hours post-dosee
Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments	Pre-dose to 2 hours post-dose
Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test	Pre-dose to 24 hours post-dose

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026