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Completed

NCT Number: NCT01970072

A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam Tosylate

Drug

midazolam

Drug

Primary outcomes

  1. 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

  2. Bispectral index (BIS) and Modified Observer's Assessment of Alertness/Sedation(MOAA/S) score assessments

    Time frame: Pre-dose to 2 hours post-dose

  3. Adverse event；Vital sign；Physical examination；Laboratory examination；ECG；The nervous system function test

    Time frame: Pre-dose to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2013
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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