Healthy
Conditions
Brief summary
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)
Interventions
DRUGEthanolic Solution From HFA134a-MDI - low
DRUGEthanolic Solution From HFA134a-MDI - medium
DRUGEthanolic Solution From HFA134a-MDI - high
DRUGEthanolic Solution From Respimat®
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations | up to 15 min after inhalation |
Secondary
| Measure | Time frame |
|---|---|
| Time to highest breath concentration (Tmax) | up to 15 min after inhalation |
| Number of patients with adverse events | up to 5 days |
| 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 |
Outcome results
None listed