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Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

Safety Issues Clinical Trial

Official title:
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

Clinical Trial Summary

A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

Clinical Trial Description

Evaluating the potential for additive or synergistic effects of alcohol when coadministered with remimazolam. Female subjects were selected because they represent the population at greatest risk for victimization in drug-facilitated sexual assault. In addition, females have a slower ethanol metabolism, therefore, the effects of remimazolam, if coadministered with alcohol, may last longer. Hence, this population represents the worst-case scenario in evaluating the risk of remimazolam misuse in drug-facilitated assault. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04113343
Study type Interventional
Source Paion UK Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 30, 2017
Completion date August 9, 2017
View Details
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