NCT00964535

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-08-25
• Last updated: 2010-02-15

Locations

1 site across 1 country: United Kingdom