Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects

The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus

Main inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Males and females, 18-60 (inclusive) years of age.
3. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).
4. Weight at least 50 kg.

Main exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment.
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
4. Known hypersensitivity to the active substance(s) or the lactose.
5. Pregnant or lactating females and females of childbearing potential not using proper contraception.
6. Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
7. Administration of another investigational medicinal product within 90 days prior to first study treatment administration.