Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte; a Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects (ADECO)

NCT01627158 Phase 1 COMPLETED

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.

Details

Lead sponsor	Orion Corporation, Orion Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	72
Start date	2012-06
Completion	2012-10

Conditions

• Asthma

Interventions

• Budesonide/formoterol Easyhaler
• Symbicort Turbuhaler
• Charcoal and Budesonide/formoterol Easyhaler
• Charcoal and Symbicort Turbuhaler

Primary outcomes

• Pharmacokinetic parameter Cmax of plasma budesonide concentration — within 12 h
• Pharmacokinetic parameter AUCt of plasma budesonide concentration — 12 h
• Pharmacokinetic parameter Cmax of plasma formoterol concentration — 24 h
• Pharmacokinetic parameter AUCt of plasma formoterol concentration — 24 h

Countries

Germany