NCT02040597

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.

Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Beclometasone/Formoterol/Glycopyrrolate

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-01-20
• Last updated: 2021-10-29

Locations

2 sites across 1 country: Poland