Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Orion Corporation, Orion Pharma1 site in 1 country17 target enrollmentOctober 2011

ConditionsHealthy

InterventionsBudesonide Easyhaler Formoterol Turbohaler Forte

DrugsBudesonide Formoterol

Overview

Phase: Not Applicable
Intervention: Budesonide
Conditions: Healthy
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 17
Locations: 1
Primary Endpoint: Cmax of Budesonide and Formoterol
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

December 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Orion Corporation, Orion Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males and females, 18-55 years of age.
•Normal weight at least 50 kg.

Exclusion Criteria

•Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
•Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study
•Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
•Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
•Pregnant or lactating females.