NCT02264145已完成1 期
The Effect of Alcoholic-carrier Solutions Within-devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations
研究概览
简要总结
The study objective is to determine the effect of the ethanolic solutions inhaled from the Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4 of ethanol) on the breath alcohol measurements in healthy volunteers.
Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open, randomized, four-way-cross-over design is chosen. The randomization is balanced and stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)
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
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoker volunteers without dental prothesis
- •18 to 45 years old, male or female
- •No clinically significant abnormal conditions at the screening visit. A clinically significant disease is defined as one, which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study or the subjects ability to participate in the study
- •Volunteer with gamma-glutamyl-transferase (GGT) level < 32 IU/L
- •Volunteer is able to sign informed consent in accordance with Good Clinical Practice and local legislation
- •Volunteers is able to be trained in the performance of technically satisfactory pulmonary function tests
- •Volunteer is able to be trained in the correct use HFA-MDI, Respimat® and Ethylometer
- •Affiliated to the National Social Security System
排除标准
- •Subjects who are already taking other investigational drugs or who have taken part in another trial during the past month
- •Consumption of alcoholic beverage within 12 hours prior to observation period
- •Breast feeding or pregnant female or female with no medically approved contraception method (oral contraceptive, intra uterine device)
- •Subjects who have a known intolerance or hypersensitivity to aerosolized containing products and/or to any of the HFA-MDI or Respimat® excipient
- •Volunteer with history of drug abuse and/or alcoholism
- •Intensive exercise one week prior to the study
- •Major exposure to dust, smoke or pollution one week prior to the study
- •Subjects with an upper or lower respiratory tract infection within the previous four weeks to screening. This is to insure no reduced alcohol absorption by mucus
- •Current psychiatric disorders
- •Previous inclusion in the randomized period of this study
- •Subjects on concomitant medications
研究组 & 干预措施
Ethanolic Solution From HFA134a-MDI - high
Experimental
干预措施: Ethanolic Solution From HFA134a-MDI - high (Drug)
Ethanolic Solution From HFA134a-MDI - low
Experimental
干预措施: Ethanolic Solution From HFA134a-MDI - low (Drug)
Ethanolic Solution From HFA134a-MDI - medium
Experimental
干预措施: Ethanolic Solution From HFA134a-MDI - medium (Drug)
Ethanolic Solution From Respimat®
Experimental
干预措施: Ethanolic Solution From Respimat® (Drug)
结局指标
主要结局
Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations
时间窗: up to 15 min after inhalation
次要结局
- Breath alcohol concentration profile within each formulation(up to 15 min after inhalation)
- Maximum duration of alcohol detection exhaled air (Td) for each formulation(up to 15 min after inhalation)
- Highest breath alcohol concentration measured (Cmax)(up to 15 min after inhalation)
- Time to highest breath concentration (Tmax)(up to 15 min after inhalation)
- Number of patients with adverse events(up to 5 days)
研究者
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