drugset / Trial / NCT02040597

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

NCT02040597 ↗

Phase 1 Completed 42 enrolled Chiesi Farmaceutici S.p.A.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Beclometasone/Formoterol/Glycopyrrolate Unknown — Inhaled