Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

Phase 1

Completed

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

• Registration Number: NCT02162485
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

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

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Exclusion Criteria

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years
• Any condition requiring regular 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salmeterol/fluticasone Easyhaler	Salmeterol/fluticasone Easyhaler	Single dose of Salmeterol/fluticasone Easyhaler
Salmeterol/fluticasone Easyhaler with charcoal	Salmeterol/fluticasone Easyhaler with charcoal	Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
Seretide Diskus	Seretide Diskus	Single dose of Seretide Diskus
Seretide Diskus with charcoal	Seretide Diskus with charcoal	Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules)

Primary Outcome Measures

Name	Time	Method
Cmax of plasma salmeterol and fluticasone propionate	within 34 h
AUCt of plasma salmeterol and fluticasone propionate	34 h

Trial Locations

Locations (1)

Orion Pharma Pharmacology Unit; 🇫🇮 Espoo, Finland