NCT01593826

Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

Pharmacokinetic Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 320/9 Microg/Inhalation and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Charcoal and Budesonide/formoterol Easyhaler 320/9 microg	2 inhalations as a single dose
DRUG	Charcoal and Symbicort Turbuhaler	2 inhalations as a single dose
DRUG	Budesonide/formoterol Easyhaler 320/9 microg	2 inhalations as a single dose
DRUG	Symbicort Turbuhaler forte	2 inhalations as a single dose

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-05-08
• Last updated: 2012-11-22

Locations

1 site across 1 country: Finland