NCT01668121

Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Two Batches of Symbicort Turbuhaler and Budesonide/Formoterol Easyhaler: Randomised, Double-blind, Double-dummy, Single Centre, Single Dose, Crossover Study in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Symbicort Turbohaler
DRUG	Budesonide/formoterol Easyhaler

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-08-17
• Last updated: 2012-11-27

Locations

1 site across 1 country: Germany