Trials / Completed
CompletedNCT01116089
Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
PHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bramitob® administered by PARI LC® PLUS nebulizer | (tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days |
| DRUG | Bramitob® administered by PARI eFlow® rapid electronic nebulizer | (tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-05-04
- Last updated
- 2020-07-31
Locations
5 sites across 3 countries: Czechia, Moldova, Slovakia
Source: ClinicalTrials.gov record NCT01116089. Inclusion in this directory is not an endorsement.