Overview

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

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Orion Corporation, Orion Pharma
Treatments:
Charcoal
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Salmeterol Xinafoate
Criteria
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.