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

Inclusion criteria

• Good general health ascertained by detailed medical history, and laboratory and physical examinations
• Finnish speaking males and females, 18-55 (inclusive) years of age
• Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2
• Weight at least 50 kg
• Regular intestinal transit

Exclusion criteria

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
• Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into the study
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
• Known hypersensitivity to the active substance(s) or to any of the excipients of the drug
• Pregnant or lactating females
• Recent or current (suspected) drug abuse or positive result in the drugs abuse test
• Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent])
• Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study
• Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration
• Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
• Administration of another investigational drug within 90 days prior to the first study treatment administration
• Unsuitable veins for repeated venipuncture or for cannulation
• Inability to learn the correct inhalation technique
• Inability to participate in all treatment periods