Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Orion Corporation, Orion Pharma1 site in 1 country50 target enrollmentJanuary 2013

ConditionsAsthma

InterventionsSF Easyhaler and charcoal Seretide Diskus and charcoal Seretide Diskus SF Easyhaler

DrugsSeretide Diskus and charcoal Seretide Diskus SF Easyhaler and charcoal SF Easyhaler

Overview

Phase: Phase 1
Intervention: SF Easyhaler and charcoal
Conditions: Asthma
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 50
Locations: 1
Primary Endpoint: Pharmacokinetic parameter Cmax of plasma salmeterol concentration
Status: Completed
Last Updated: 12 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 Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

May 2013

Last Updated

12 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 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.