Double-blind, Randomized, Placebo and Active Controlled Study to Assess the Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults(Zolpidem or Brotizolam)
Overview
- Phase
- Phase 1
- Intervention
- Flumazenil
- Conditions
- Healthy
- Sponsor
- Coeruleus Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject understood and voluntarily signed an informed consent form prior to any study-mandated procedure.
- •Male or female aged 18-65 at screening. Women of childbearing potential must have a negative pregnancy test at the screening visit and use a reliable method of contraception during the entire study duration (e.g.
- •Contraceptive pill; Intra-uterine device; Contraceptive injection (prolonged-release gestagen); Subdermal implantation;Vaginal ring or Transdermal patch).
- •Body mass index ≥ 18.5 and \< 32 kg/m
- •Normal sleep habits, i.e. usual self-reported total sleep time \> 6 h; usual self-reported time to fall asleep \< 30 min; usual bedtime between 10:30 pm and 01:00 am.
- •Subject is in good health as determined by a medical history, physical examination and ECG.
- •Negative any use of illicit drug, alcohol (ethanol), stimulants.
Exclusion Criteria
- •Any use of medications within 1 month prior to screening visit, except for contraceptive pills.
- •Any sleep associated complains.
- •Previous exposure to Benzodiazepines and/or non-Benzodiazepine hypnotic drugs within 3 months prior to study initiation.
- •History of Epilepsy and or anti-epileptic drugs.
- •Excessive caffeine consumption (≥ 500 mg per day).
- •Pregnancy or breast feeding.
- •Night shift workers within 1 month prior to the screening visit.
- •Clinically relevant ECG abnormalities.
- •History of alcohol or drug abuse within 3 years prior to the screening visit.
- •Cognitive Behavioral Therapy (CBT) started within 1 month prior to the screening visit.
Arms & Interventions
Brotizolam
Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo
Intervention: Flumazenil
Brotizolam
Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo
Intervention: Placebo
Zolpidem
Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo.
Intervention: Flumazenil
Zolpidem
Treatment response will be evaluated for each treatment arm. Good Response (GR) - is considered as an improvement of 30% in efficacy parameters of Flumazenil treatment in comparison to placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs(6 months)