Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s): Ulla Sairanen, MSc, Study Director, Affiliation: Orion Corporation, Orion Pharma
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Medicines Evaluation Unit, Manchester M23 9QZ, United Kingdom
Additional Information
Starting date: September 2009
Last updated: February 12, 2010
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