Drug-drug Interaction Study of CHF5993 With Cimetidine

Summary

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

Timeline

Start

2014-05

Primary completion

2014-07

Completion

2014-09

Publications

• Results Mariotti F, Ciurlia G, Spaccapelo L, Muraro A, Acerbi D. A Two-Period Open-Label, Single-Dose Crossover Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Between Cimetidine and Inhaled Extrafine CHF 5993. Eur J Drug Metab Pharmacokinet. 2017 Apr;42(2):269-279. doi: 10.1007/s13318-016-0345-2.

Drugs

Indications