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

NCT02264145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-15

No results posted yet for this study

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)

Conditions

  • Healthy

Interventions

DRUG

Ethanolic Solution From HFA134a-MDI - low

DRUG

Ethanolic Solution From HFA134a-MDI - medium

DRUG

Ethanolic Solution From HFA134a-MDI - high

DRUG

Ethanolic Solution From Respimat®

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-11-30
Primary Completion
1998-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264145 on ClinicalTrials.gov