Official Title: “Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Drug: budesonide and formoterol 200/6 microg
  • 2 inhalations as a single dose
• Drug: budesonide and formoterol 200/6 microg
  • 2 inhalations as a single dose
• Drug: budesonide and formoterol 200/6 microg
  • 2 inhalations as a single dose with the concurrent charcoal blockage
• Drug: budesonide and formoterol 200/6 microg
  • 2 inhalations as a single dose with the concurrent charcoal blockage

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Budesonide/formoterol Easyhaler
• Experimental: Charcoal and Budesonide/formoterol EH
• Active Comparator: Symbicort Turbohaler
• Active Comparator: Charcoal and Symbicort Turbohaler

Primary Measures

• Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
  • Time Frame: within 24 h
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Orion Corporation, Orion Pharma

Overall Clinical Trial Officials and Contacts

Ulla Sairanen, MSc Study Director Orion Corporation, Orion Pharma  

Information obtained from ClinicalTrials.gov on September 01, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00964535

Study ID Number: 3103002

ClinicalTrials.gov Identifier: NCT00964535

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency