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Study to Investigate Safety and Tolerability of BI 1744 CL in Free Dose Combination With Tiotropium Bromide Both Administered by Respimat® in Healthy Male Volunteers

NCT02259946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-10-09

No results posted yet for this study

Summary

Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744 CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their dose proportionality, and to explore the pharmacodynamic effects of the treatments on selected metabolic and respiratory parameters

Conditions

  • Healthy

Interventions

DRUG

BI 1744 CL

DRUG

Placebo

DRUG

Tiotropium bromide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-07-31

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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 NCT02259946 on ClinicalTrials.gov