Pharmacokinetic Pilot Study on Budesonide/Formoterol
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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.
Condition or disease
Drug: BudesonideDrug: FormoterolDevice: EasyhalerDevice: Turbohaler Forte
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy males and females, 18-55 years of age.
Normal weight at least 50 kg.
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.