Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µg/Inhalation: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

NCT03060044 Phase 1 COMPLETED

Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects

Details

Lead sponsor	Orion Corporation, Orion Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	64
Start date	2016-07
Completion	2016-11

Conditions

• Asthma

Interventions

• Salmeterol/fluticasone Easyhaler
• Salmeterol/fluticasone Easyhaler with charcoal
• Seretide Diskus
• Seretide Diskus with charcoal

Primary outcomes

• Cmax of plasma salmeterol and fluticasone propionate — 0 hour to 34 hours after study treatment administration
• AUCt of plasma salmeterol and fluticasone propionate — 0 hour to 34 hours after study treatment administration

Countries

Finland