Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Inclusion Criteria:

• Males or females aged 18-60 years with documented diagnosis of asthma
• Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
• The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria:

• Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
• Respiratory infection within 4 weeks preceding the screening
• Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
• Any disorder or 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