Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Orion Corporation, Orion Pharma
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate