NCT02743013

Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers

Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993, Administered Via the Multi-dose Reservoir NEXThaler® Dry Powder Inhaler and Via a HFA-pressurised Metered Dose Inhaler With and Without Valved Holding Chamber, in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• COPD

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-04-19
• Last updated: 2021-07-02

Locations

1 site across 1 country: Belgium