The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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