drugset / Trial / NCT02264145

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

NCT02264145

Phase 1 Completed 20 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
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.