NCT01766843

Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Seretide Diskus and charcoal	2 inhalations as a single dose
DRUG	Seretide Diskus	2 inhalations as a single dose
DRUG	SF Easyhaler and charcoal	2 inhalations as a single dose
DRUG	SF Easyhaler	2 inhalations as a single dose

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-01-11
• Last updated: 2014-01-03

Locations

1 site across 1 country: Finland