Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Study Overview
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Brief Summary
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Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects

Official Title
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Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µg/Inhalation: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Conditions
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Asthma

Intervention / Treatment
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* Drug: Salmeterol/fluticasone Easyhaler
* Drug: Salmeterol/fluticasone Easyhaler with charcoal
* Drug: Seretide Diskus
* Drug: Seretide Diskus with charcoal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent obtained good general health ascertained by detailed medical history, and laboratory and physical examinations Exclusion Criteria: evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmeterol/fluticasone Easyhaler<br>single dose of Salmeterol/fluticasone Easyhaler | Drug: Salmeterol/fluticasone Easyhaler<br> <br> |
| Experimental: Salmeterol/fluticasone Easyhaler with charcoal<br>Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration | Drug: Salmeterol/fluticasone Easyhaler with charcoal<br> <br> |
| Active Comparator: Seretide Diskus<br>Single dose of Seretide Diskus | Drug: Seretide Diskus<br> <br> |
| Active Comparator: Seretide Diskus with charcoal<br>Single dose of Seretide Diskus with concomitant charcoal administration | Drug: Seretide Diskus with charcoal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of plasma salmeterol and fluticasone propionate |  | 0 hour to 34 hours after study treatment administration | 
| AUCt of plasma salmeterol and fluticasone propionate |  | 0 hour to 34 hours after study treatment administration |