drugset / Trial / NCT01668121

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

NCT01668121 ↗

Phase 1 Completed 48 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2012-08
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide/formoterol Unknown — Inhaled

Indications