Open-label, Randomized, Single Dose, 2-sequence, 2-period Cross-over Study to Investigate the Effect of Inhibition of the Organic Cation Transport in the Kidneys by Cimetidine on the Pharmacokinetics of the CHF5993 in Healthy Volunteers

NCT02287272 Phase 1 COMPLETED

The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993 (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI administered alone or at steady-state of Cimetidine

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 1
Status	COMPLETED
Enrolment	25
Start date	2014-05
Completion	2014-09

Conditions

• COPD

Interventions

• CHF 5993 pMDI
• Cimetidine plus CHF5993 pMDI

Primary outcomes

• Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of Glycopyrronium Bromide — pre-dose, 5, 10,15,30min, 1,2,4,6,8,12hr post-dose

Countries

Belgium