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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Charcoal; Formoterol Fumarate

Criteria

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