drugset / Trial / NCT02264145
The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
RandomizedCrossoverDouble-blindTreatment
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)
Timeline
- Start
- 1998-11
- Primary completion
- 1998-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 15.5 mg | Inhaled |
| Subject | Alcohol | Other / unclassified | 18.4 unknown | Inhaled |
| Subject | Alcohol | Other / unclassified | 31.2 mg | Inhaled |
| Subject | Alcohol | Other / unclassified | 62.4 mg | Inhaled |
Indications
No indication recorded.