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

Asthma Clinical Trial

— KINECO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964535
• Other study ID #: 3103002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 24, 2009
• Last updated: February 12, 2010
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations		within 24 h	No