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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Mar 2020

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At a glance

  • Drugs Remimazolam (Primary) ; Midazolam
  • Indications Anaesthesia; Sedation
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Jiangsu Hengrui Medicine Co.

    • Most Recent Events

    • 13 Mar 2020 Results (n=87; Chinese volunteers) of two clinical studies: NCT01970072: Midazolam based and NCT03444480 Flumazenil based assessing residual psychomotor effects of remimazolam and their recovery from sedating treatment in 2 simulated clinical settings: single dose administration for sedation initiation and constant rate infusion for sedation maintenance were published in the Clinical Therapeutics
    • 30 Jan 2018 Status changed from recruiting to completed.
    • 05 Nov 2013 New trial record

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