CompletedPhase 1

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

Poland42 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexALL

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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

What they're measuring

Glycopyrrolate area under the curve (AUC)

Timeframe: over 72 h after single administration

Trial details

NCT IDNCT02040597

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

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