Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.

Inclusion Criteria:

• Healthy males and females aged 18-60 years
• Normal weight, at least 50 kg

Exclusion Criteria:

• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
• Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in 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 the excipient of the drug.
• Pregnant or lactating females.