Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
NCT02743013 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-07-02
Summary
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
Conditions
Interventions
- DRUG
-
CHF 5993 100/6/12,5 pMDI
- DRUG
-
CHF 5993 100/6/12,5 DPI Test 1
- DRUG
-
CHF 5993 100/6/12,5 DPI Test 2
- DRUG
-
CHF 5993 100/6/12,5 pMDI replicate
- DRUG
-
CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber
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
- 2016-04-30
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- Belgium
Study Locations
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