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

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Seretide Diskus; Drug: SF Easyhaler; Drug: Seretide Diskus and charcoal; Drug: SF Easyhaler and charcoal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766843

3106007, EudraCT 2012-00378-41

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 4 patient groups

Seretide Diskus and charcoal

Active Comparator group

Description:

Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal

Treatment:

Drug: Seretide Diskus and charcoal

Seretide Diskus

Active Comparator group

Description:

Single-dose of Seretide Diskus (50/500 mcg/inhalation)

Treatment:

Drug: Seretide Diskus

SF Easyhaler and charcoal

Experimental group

Description:

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal

Treatment:

Drug: SF Easyhaler and charcoal

SF Easyhaler

Experimental group

Description:

Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)

Treatment:

Drug: SF Easyhaler