drugset / Trial / NCT02254174

Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers

NCT02254174

Phase 1 Completed 36 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®). Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to tiotropium and salmeterol administered as individual mono substances from the marketed products. Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol in a PE (Polyethylene) capsule administered via the HandiHaler® 2

Timeline

Start
2006-03
Primary completion
2006-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Salmeterol Other / unclassified 25 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled
Subject Tiotropium Other / unclassified 7.5 ug Inhaled
Subject Tiotropium Other / unclassified 18 ug Inhaled
Subject salmeterol xinafoate Unknown 50 ug Inhaled

Indications

No indication recorded.