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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Budesonide/formoterol Easyhaler	budesonide and formoterol 200/6 microg	-
Charcoal and Budesonide/formoterol EH	budesonide and formoterol 200/6 microg	-
Symbicort Turbohaler	budesonide and formoterol 200/6 microg	-
Charcoal and Symbicort Turbohaler	budesonide and formoterol 200/6 microg	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations	within 24 h

Secondary Outcome Measures

Name	Time	Method

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