drugset / Trial / NCT02259946

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

Phase 1 Completed 48 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2006-04
Primary completion
2006-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Olodaterol Small molecule 2.5 ug Inhaled
Subject Olodaterol Small molecule 5 ug Inhaled
Subject Olodaterol Small molecule 10 ug Inhaled
Subject Olodaterol Small molecule 20 ug Inhaled
Subject Olodaterol Small molecule 40 ug Inhaled
Subject Tiotropium Other / unclassified 5 ug Inhaled
Subject Tiotropium Other / unclassified 10 ug Inhaled

Indications

No indication recorded.