Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Study Overview
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Brief Summary
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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

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: salmeterol-fluticasone
* Drug: salmeterol-fluticasone
* Drug: salmeterol-fluticasone
* Drug: salmeterol-fluticasone


Participation Criteria
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Eligibility Criteria
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Main inclusion Criteria: Written informed consent (IC) obtained. Males and females, 18-60 (inclusive) years of age. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2). Weight at least 50 kg. Main exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease. Any condition requiring regular concomitant treatment. 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. Known hypersensitivity to the active substance(s) or the lactose. Pregnant or lactating females and females of childbearing potential not using proper contraception. Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration. Administration of another investigational medicinal product within 90 days prior to first study treatment administration.

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 |
| --- | --- |
| Active Comparator: Seretide Diskus<br>salmeterol-fluticasone 2 inhalations as a single dose | Drug: salmeterol-fluticasone<br>* Seretide Diskus 50/250 µg/dose<br>|
| Experimental: Salmeterol/fluticasone Easyhaler, E<br>salmeterol-fluticasone 2 inhalations as a single dose | Drug: salmeterol-fluticasone<br>* Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E<br>|
| Experimental: Salmeterol/fluticasone Easyhaler, F<br>salmeterol-fluticasone 2 inhalations as a single dose | Drug: salmeterol-fluticasone<br>* Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F<br>|
| Experimental: Salmeterol/fluticasone Easyhaler, G<br>salmeterol-fluticasone 2 inhalations as a single dose | Drug: salmeterol-fluticasone<br>* Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of salmeterol | Cmax of salmeterol | between 0-34 hours after dosing | 
| Peak plasma concentration (Cmax) of fluticasone propionate | Cmax of fluticasone propionate | between 0-34 hours after dosing | 
| Area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to the last sample with the quantifiable concentration | 0-34 hours after dosing | 
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate | AUC from time zero to the last sample with the quantifiable concentration | 0-34 hours after dosing | 
| Truncated area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to 30 min after study treatment administration | 0-30 minutes after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to infinity | 0-34 hours after dosing and extrapolation | 
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate | AUC from time zero to infinity | 0-34 hours after dosing and extrapolation | 
| The time to reach the maximum concentration (tmax) of salmeterol | tmax of salmeterol | 0-34 hours after dosing | 
| The time to reach the maximum concentration (tmax) of fluticasone propionate | tmax of fluticasone propionate | 0-34 hours after dosing | 
| The terminal elimination half-life (t1/2) of salmeterol | t1/2 of salmeterol | 0-34 hours after dosing | 
| The terminal elimination half-life (t1/2) of fluticasone propionate | t1/2 of fluticasone propionate | 0-34 hours after dosing |