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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Glycopyrrolate

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