Status:
COMPLETED
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00964535
Start Date
September 1 2009
End Date
February 1 2010
Last Update
February 15 2010
Active Locations (1)
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1
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ