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Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

2019-10-08 08:47:30 | BioPortfolio

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

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

Conditions

Safety Issues

Intervention

Remimazolam, Alcohol

Location

PRA Health Sciences (PRA) - Early Development Services
Salt Lake City
Utah
United States
84106

Status

Completed

Source

Paion UK Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-08T08:47:30-0400

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