NCT03238482

Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)

Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler 50/250 µg/Dose Products and Seretide Diskus 50/250 µg/Dose in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (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 absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	salmeterol-fluticasone	Seretide Diskus 50/250 µg/dose
DRUG	salmeterol-fluticasone	Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
DRUG	salmeterol-fluticasone	Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
DRUG	salmeterol-fluticasone	Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G

Timeline

• Start date: 2017-08-16
• Primary completion: 2017-12-19
• Completion: 2017-12-19
• First posted: 2017-08-03
• Last updated: 2018-04-06

Locations

1 site across 1 country: Finland