drugset / Trial / NCT01012739

Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

NCT01012739

Phase 2 Completed 35 enrolled Novartis Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

Summary

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

Timeline

Start
2009-10
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 60 ug Inhaled
Subject Indacaterol Other / unclassified 120 ug Inhaled
Subject Indacaterol Other / unclassified 150 ug Inhaled

Indications