Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Salmeterol/fluticasone Easyhaler with charcoal; Drug: Seretide Diskus; Drug: Salmeterol/fluticasone Easyhaler; Drug: Seretide Diskus with charcoal

• Registration Number: NCT03060044
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• written informed consent obtained
• good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria

• evidence of a clinically significant cardiovascular, renal, hepatic, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
• any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed
• known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug
• pregnant or lactating females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salmeterol/fluticasone Easyhaler with charcoal	Salmeterol/fluticasone Easyhaler with charcoal	Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration
Seretide Diskus	Seretide Diskus	Single dose of Seretide Diskus
Salmeterol/fluticasone Easyhaler	Salmeterol/fluticasone Easyhaler	single dose of Salmeterol/fluticasone Easyhaler
Seretide Diskus with charcoal	Seretide Diskus with charcoal	Single dose of Seretide Diskus with concomitant charcoal administration

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orion Pharma pharmacology Unit; 🇫🇮 Espoo, Finland