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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration
Placebo - only excipients with no API
Rambam Medical Center
Haifa, Israel
Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs
Time frame: 6 months
Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs
Time frame: 6 months
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