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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Seretide Diskus and charcoal
* Drug: Seretide Diskus
* Drug: SF Easyhaler and charcoal
* Drug: SF Easyhaler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seretide Diskus and charcoal<br>Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal | Drug: Seretide Diskus and charcoal<br>* 2 inhalations as a single dose<br>|
| Active Comparator: Seretide Diskus<br>Single-dose of Seretide Diskus (50/500 mcg/inhalation) | Drug: Seretide Diskus<br>* 2 inhalations as a single dose<br>|
| Experimental: SF Easyhaler and charcoal<br>Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal | Drug: SF Easyhaler and charcoal<br>* 2 inhalations as a single dose<br>|
| Experimental: SF Easyhaler<br>Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) | Drug: SF Easyhaler<br>* 2 inhalations as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter Cmax of plasma salmeterol concentration |  | Within 34 h | 
| Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration |  | Within 34 h | 
| Pharmacokinetic parameter AUCt of plasma salmeterol concentration |  | within 34 h | 
| Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration |  | within 34 h |