Pharmacokinetic Pilot Study on Budesonide/Formoterol

Study Overview
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Brief Summary
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The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Official Title
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Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Budesonide
* Drug: Formoterol
* Device: Easyhaler
* Device: Turbohaler Forte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females, 18-55 years of age. Normal weight at least 50 kg. Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study. Known hypersensitivity to the active substance(s) or to any of the excipients of the drug. Pregnant or lactating females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide/Formoterol Easyhaler A<br> | Drug: Budesonide<br>* Single inhalation<br>Drug: Formoterol<br>* Single inhalation<br>Device: Easyhaler<br>* Inhaler device<br>|
| Experimental: Budesonide/Formoterol Easyhaler B<br> | Drug: Budesonide<br>* Single inhalation<br>Drug: Formoterol<br>* Single inhalation<br>Device: Easyhaler<br>* Inhaler device<br>|
| Experimental: Budesonide/Formoterol Easyhaler C<br> | Drug: Budesonide<br>* Single inhalation<br>Drug: Formoterol<br>* Single inhalation<br>Device: Easyhaler<br>* Inhaler device<br>|
| Active Comparator: Budesonide/Formoterol Turbohaler Forte<br> | Drug: Budesonide<br>* Single inhalation<br>Drug: Formoterol<br>* Single inhalation<br>Device: Turbohaler Forte<br>* Inhaler device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Budesonide and Formoterol |  | 24 hours | 
| AUCt of Budesonide and Formoterol |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf of Budesonide and Formoterol |  | 24 hours | 
| tmax of Budesonide and Formoterol |  | 24 hours | 
| t1/2 of Budesonide and Formoterol |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer study