Trials / Completed
CompletedNCT01280175
Foster With or Without Charcoal Block or Aerochamber Plus
Pharmacokinetics and Lung Bioavailability of BDP/Formoterol HFA Fixed Combination After Single Administration in 12 Healthy Volunteers Using the Standard Actuator With or Without Charcoal Block or the Aerochamber Spacer.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | charcoal block | |
| DEVICE | Aerochamber Plus spacer | |
| DRUG | pMDI standard actuator |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2007-02-01
- Completion
- 2007-02-01
- First posted
- 2011-01-20
- Last updated
- 2020-08-03
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT01280175. Inclusion in this directory is not an endorsement.