Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

Study Overview
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Brief Summary
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The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.

Official Title
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Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler, Symbicort Turbuhaler; an Open, Single Center, Single Dose Study With 3-way Crossover Design in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Budesonide/Formoterol Batch 1
* Drug: Budesonide/Formoterol Batch 2
* Drug: Budesonide/Formoterol Batch 1 and charcoal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health ascertained by detailed medical history, and laboratory and physical examinations Finnish speaking males and females, 18-55 (inclusive) years of age Normal weight defined as body mass index (BMI) > 19 and < 30 kg/m2 Weight at least 50 kg Regular intestinal transit Exclusion Criteria: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease Any abnormal value of laboratory, vital signs, 12-lead electrocardiogram or physical exam which may in the opinion of the investigator interfere with the test results or cause a health risk for the subject if he/she takes part into 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 to any of the excipients of the drug Pregnant or lactating females Recent or current (suspected) drug abuse or positive result in the drugs abuse test Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent]) Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration Administration of another investigational drug within 90 days prior to the first study treatment administration Unsuitable veins for repeated venipuncture or for cannulation Inability to learn the correct inhalation technique Inability to participate in all treatment periods

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: 1<br>Budesonide/Formoterol Batch 1 | Drug: Budesonide/Formoterol Batch 1<br>* Single, inhaled dose<br>* Other names: Symbicort Turbuhaler;|
| Experimental: 2<br>Budesonide/Formoterol Batch 2 | Drug: Budesonide/Formoterol Batch 2<br>* Single, inhaled dose<br>* Other names: Symbicort Turbuhaler;|
| Experimental: 3<br>Budesonide/Formoterol Batch 1 and charcoal | Drug: Budesonide/Formoterol Batch 1 and charcoal<br>* Single, inhaled dose<br>* Other names: Symbicort Turbuhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler |  | 1 day | 

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