drugset / Trial / NCT01484197
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
RandomizedCrossoverTriple-blindTreatment
Summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 37.5 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 75 ug | Inhaled |