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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •Known hypersensitivity to drugs of the same class as the study treatment, or any excipients of the drug formulation.
- •Treatment with another investigational drug within 1 month prior to the screening visit.
- •History of severe head injury.
研究组 & 干预措施
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
干预措施: Flumazenil (Drug)
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
干预措施: Placebo (Drug)
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.
干预措施: Flumazenil (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of single dose administration of sublingual Flumazenil 0.4 mg as a reversal drug for the hypnotic effect of sleep/ hypnotic drugs
时间窗: 6 months
次要结局
- 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)