drugset / Trial / NCT01738087
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
RandomizedCrossoverOpen-labelTreatment
Summary
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths. At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
Timeline
- Start
- 2012-11
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 500 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 24 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 400 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 800 ug | Inhaled |