drugset / Trial / NCT01012739
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 60 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 120 ug | Inhaled |
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |