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

NCT01593826 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	2012-05
Completion	2012-10

Conditions

• Asthma

Interventions

• Charcoal and Budesonide/formoterol Easyhaler 320/9 microg
• Charcoal and Symbicort Turbuhaler
• Budesonide/formoterol Easyhaler 320/9 microg
• Symbicort Turbuhaler forte

Primary outcomes

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

Countries

Finland