Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

Study Overview
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Brief Summary
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The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Official Title
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Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation

Conditions
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Asthma

Intervention / Treatment
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* Drug: budesonide and formoterol 200/6 microg
* Drug: budesonide and formoterol 200/6 microg
* Drug: budesonide and formoterol 200/6 microg
* Drug: budesonide and formoterol 200/6 microg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18-60 years with documented diagnosis of asthma Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value The asthma should be stable on the same regular treatment for at least 4 weeks before screening. Exclusion Criteria: Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening Respiratory infection within 4 weeks preceding the screening Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide Any disorder or 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

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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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide/formoterol Easyhaler<br> | Drug: budesonide and formoterol 200/6 microg<br>* 2 inhalations as a single dose<br>* Other names: Budesonide/formoterol Easyhaler 200/6 microg/inhalation;|
| Experimental: Charcoal and Budesonide/formoterol EH<br> | Drug: budesonide and formoterol 200/6 microg<br>* 2 inhalations as a single dose with the concurrent charcoal blockage<br>* Other names: Budesonide/formoterol Easyhaler 200/6 microg/inhalation;|
| Active Comparator: Symbicort Turbohaler<br> | Drug: budesonide and formoterol 200/6 microg<br>* 2 inhalations as a single dose<br>* Other names: Symbicort Turbohaler 200/6 microg/inhalation;|
| Active Comparator: Charcoal and Symbicort Turbohaler<br> | Drug: budesonide and formoterol 200/6 microg<br>* 2 inhalations as a single dose with the concurrent charcoal blockage<br>* Other names: Symbicort Turbohaler 200/6 microg/inhalation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations |  | within 24 h |