Who is sponsoring NCT01386996?

NCT01386996 is sponsored by Orion Corporation, Orion Pharma.

What drugs are being tested in NCT01386996?

Interventions: Budesonide/formoterol Easyhaler 320/9 microg, Symbicort Turbuhaler forte.

What is the status of NCT01386996?

NCT01386996 is currently COMPLETED.

Last reviewed 2011-12-21 · How we verify

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

NCT01386996 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	74
Start date	2011-07
Completion	2011-11

Conditions

Asthma

Interventions

Budesonide/formoterol Easyhaler 320/9 microg
Symbicort Turbuhaler forte

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

Finland