A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers

Summary

This study will be conducted to establish the relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a spacer device. Administration under each condition will occur with the concomitant administration of activated charcoal to estimate exposure through the lung and without activated charcoal to estimate total systemic exposure.

Timeline

Start

2016-11-04

Primary completion

2017-03-27

Completion

2017-03-27

Publications

• Background Gillen M, Forte P, Svensson JO, Lamarca R, Burke J, Rask K, Larsdotter Nilsson U, Eckerwall G. Effect of a spacer on total systemic and lung bioavailability in healthy volunteers and in vitro performance of the Symbicort(R) (budesonide/formoterol) pressurized metered dose inhaler. Pulm Pharmacol Ther. 2018 Oct;52:7-17. doi: 10.1016/j.pupt.2018.08.001. Epub 2018 Aug 2.

Drugs

Indications

No indication recorded.