Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

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

Official Title
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Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: 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: Budesonide/formoterol
* Other: Charcoal
* Drug: Symbicort Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained Body mass index > 19 and < 30kg/m2, weight at least 50 kg Good general health ascertained by detailed medical history, and laboratory and physical examinations 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 (including vitamins and herbal products) or likely to need any concomitant treatment during a study. Known hypersensitivity to the active substance(s) or the excipient of the drug Pregnant and 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: Charcoal and Budesonide/formoterol Easyhaler A<br>160/4.5microg/inhalation Charcoal | Drug: Budesonide/formoterol<br>* 2 inhalations as a single dose<br>* Other names: Budesonide/formoterol 160/4.5microg;Other: Charcoal<br> <br> |
| Experimental: Charcoal and Budesonide/formoterol Easyhaler B<br>160/4.5microg/inhalation Charcoal | Drug: Budesonide/formoterol<br>* 2 inhalations as a single dose<br>* Other names: Budesonide/formoterol 160/4.5microg;Other: Charcoal<br> <br> |
| Experimental: Charcoal and Budesonide/formoterol Easyhaler C<br>160/4.5microg/inhalation Charcoal | Drug: Budesonide/formoterol<br>* 2 inhalations as a single dose<br>* Other names: Budesonide/formoterol 160/4.5microg;Other: Charcoal<br> <br> |
| Active Comparator: Charcoal and Symbicort Turbuhaler<br>160/4.5microg/inhalation Charcoal | Other: Charcoal<br> <br> Drug: Symbicort Turbuhaler<br>* 2 inhalations as a single dose<br>* Other names: Symbicort Turbuhaler 160/4.5 microg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of plasma budesonide and formoterol |  | within 24 hours | 
| AUCt of plasma budesonide and formoterol |  | within 24 hours |