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

Orion Corporation, Orion Pharma1 site in 1 country72 target enrollmentMay 2012

ConditionsAsthma

InterventionsCharcoal and Symbicort Turbuhaler Symbicort Turbuhaler forte Charcoal and Budesonide/formoterol Easyhaler 320/9 microg Budesonide/formoterol Easyhaler 320/9 microg

DrugsCharcoal and Budesonide/formoterol Easyhaler 320/9 microg Charcoal and Symbicort Turbuhaler Budesonide/formoterol Easyhaler 320/9 microg Symbicort Turbuhaler forte

Overview

Phase: Phase 1
Intervention: Charcoal and Symbicort Turbuhaler
Conditions: Asthma
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 72
Locations: 1
Primary Endpoint: Pharmacokinetic parameter Cmax of plasma budesonide concentration
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

October 2012

Last Updated

13 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 aged 18-60 years.
•Normal weight, at least 50 kg.

Exclusion Criteria

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