A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

NCT01970072 ↗

Phase 1 Completed 79 enrolled Jiangsu HengRui Medicine Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2013-10-14
Primary completion: 2014-06-20
Completion: 2014-06-20

Publications

Chen X, Sang N, Song K, Zhong W, Wang H, Jiang J, Huang Y, Hu P. Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote. Clin Ther. 2020 Apr;42(4):614-624. doi: 10.1016/j.clinthera.2020.02.006. Epub 2020 Mar 13.
Zhou Y, Hu P, Huang Y, Nuoer S, Song K, Wang H, Wen J, Jiang J, Chen X. Population Pharmacokinetic/Pharmacodynamic Model-Guided Dosing Optimization of a Novel Sedative HR7056 in Chinese Healthy Subjects. Front Pharmacol. 2018 Nov 19;9:1316. doi: 10.3389/fphar.2018.01316. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	0.075 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.01 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.02 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.05 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.075 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.1 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.15 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.2 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.25 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.3 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.35 mg/kg	Intravenous

Indications

No indication recorded.