Pharmacokinetic Pilot Study Comparing Three Formulations of Budesonide/Formoterol Easyhaler 160/4.5 Microg/Inhalation and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

NCT03073057 Phase 1 COMPLETED

The purpose of this study is to compare Budesonide/formoterol Easyhaler test products 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	20
Start date	2016-01
Completion	2016-03

Conditions

• Asthma

Interventions

• Budesonide/formoterol
• Charcoal
• Symbicort Turbuhaler

Primary outcomes

• Cmax of plasma budesonide and formoterol — within 24 hours
• AUCt of plasma budesonide and formoterol — within 24 hours

Countries

Finland