Trial | NCT02040597  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    42
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.
Study Started
Jan 31
2014
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Oct 29
2021

Drug Beclometasone/Formoterol/Glycopyrrolate

  • Other names: CHF 5993 pMDI

CHF5993 pMDI Experimental

CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations

Criteria 

Inclusion Criteria:

Healthy volunteers and
Subjects with mild, moderate and severe renal impairment

Exclusion Criteria:

pregnant or lactating women
positive HIV and hepatitis serology
history of drug abuse
history of hypersensitivity to the products used in the trial
smokers
respiratory disease such as asthma and COPD
clinically relevant concomitant disease that may introduce a risk for the subjects'safety
presence of kidney stones
dialysis
No Results Posted