Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

Summary

Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known. The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.

Timeline

Start

2010-08

Primary completion

2010-10

Completion

2010-11

Drugs

Indications