Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers
NCT02359292 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-07-02
Summary
The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.
Conditions
Interventions
- DRUG
-
CHF 5993 HS 200/6/25 pMDI
- DRUG
-
CHF 5993 MS 100/6/25 pMDI
- DRUG
-
CHF 5993 HS 200/6/25 pMDI + Charcoal Block
- DRUG
-
CHF 5993 MS 100/6/25 pMDI + Charcoal Block
- DRUG
-
Placebo pMDI
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2015-04-30
- Completion
- 2015-07-31
Countries
- Belgium
Study Locations
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