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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Seretide Diskus and charcoal; Drug: Seretide Diskus; Drug: SF Easyhaler and charcoal; Drug: SF Easyhaler

• Registration Number: NCT01766843
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Seretide Diskus and charcoal	Seretide Diskus and charcoal	Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
Seretide Diskus	Seretide Diskus	Single-dose of Seretide Diskus (50/500 mcg/inhalation)
SF Easyhaler and charcoal	SF Easyhaler and charcoal	Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
SF Easyhaler	SF Easyhaler	Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter Cmax of plasma salmeterol concentration	Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration	Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration	within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration	within 34 h

Trial Locations

Locations (1)

Orion Pharma Clinical Pharmacology Unit; 🇫🇮 Espoo, Finland