drugset / Trial / NCT01071889

Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

NCT01071889

Phase 1/2 Completed 10 enrolled Coeruleus Ltd.
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with sublingual (s/l) Flumazenil in healthy volunteers as reversing the effect of the sleep/hypnotic drugs. This study is designed to collect short-term safety and tolerability data. In addition, the psychomotor/ cognitive and behavioral effects of Flumazenil will be assessed to monitor the degree and the duration of action in a single use of Flumazenil.

Timeline

Start
2010-05
Primary completion
2012-08
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Flumazenil Small molecule 0.4 mg Subcutaneous

Indications

No indication recorded.