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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.
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.
Age
40 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Biovirtus Research Site
Nadarzyn, Mokra 7, Poland
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, Poland
Start Date
January 1, 2014
Primary Completion Date
April 1, 2015
Completion Date
April 1, 2015
Last Updated
October 29, 2021
42
ACTUAL participants
Beclometasone/Formoterol/Glycopyrrolate
DRUG
Lead Sponsor
Chiesi Farmaceutici S.p.A.
NCT07477600
NCT07382258
NCT07195838
Data Source & Attribution
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