Pharmacokinetic Pilot Study on Budesonide/Formoterol

Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Inclusion Criteria:

• Healthy males and females, 18-55 years of age.
• Normal weight at least 50 kg.

Exclusion Criteria:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
• Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
• Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
• Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
• Pregnant or lactating females.