Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

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 Turbuhaler in terms of the drug absorbed into the bloodstream.

Official Title
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Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/formoterol Easyhaler
* Drug: Symbicort Turbuhaler
* Drug: Charcoal and Budesonide/formoterol Easyhaler
* Drug: Charcoal and Symbicort Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent (IC) obtained. Males and females, 18-60 (inclusive) years of age. Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Known hypersensitivity to the active substance(s) or the excipient 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide/formoterol Easyhaler<br>Budesonide/formoterol Easyhaler | Drug: Budesonide/formoterol Easyhaler<br>* Budesonide/formoterol Easyhaler<br>|
| Active Comparator: Symbicort Turbuhaler<br>Symbicort Turbuhaler | Drug: Symbicort Turbuhaler<br>* Symbicort Turbuhaler<br>|
| Experimental: Charcoal and Budesonide/formoterol Easyhaler<br> | Drug: Charcoal and Budesonide/formoterol Easyhaler<br>* Charcoal and Budesonide/formoterol Easyhaler<br>|
| Active Comparator: Charcoal and Symbicort Turbuhaler<br> | Drug: Charcoal and Symbicort Turbuhaler<br>* Charcoal and Symbicort Turbuhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter Cmax of plasma budesonide concentration |  | within 12 h | 
| Pharmacokinetic parameter AUCt of plasma budesonide concentration |  | 12 h | 
| Pharmacokinetic parameter Cmax of plasma formoterol concentration |  | 24 h | 
| Pharmacokinetic parameter AUCt of plasma formoterol concentration |  | 24 h |