Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Salmeterol/fluticasone Easyhaler with charcoal; Drug: Seretide Diskus; Drug: Salmeterol/fluticasone Easyhaler; Drug: Seretide Diskus with charcoal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03060044

3106010

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Salmeterol/fluticasone Easyhaler

Experimental group

Description:

single dose of Salmeterol/fluticasone Easyhaler

Treatment:

Drug: Salmeterol/fluticasone Easyhaler

Salmeterol/fluticasone Easyhaler with charcoal

Experimental group

Description:

Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration

Treatment:

Drug: Salmeterol/fluticasone Easyhaler with charcoal

Seretide Diskus

Active Comparator group

Description:

Single dose of Seretide Diskus

Treatment:

Drug: Seretide Diskus

Seretide Diskus with charcoal

Active Comparator group

Description:

Single dose of Seretide Diskus with concomitant charcoal administration

Treatment:

Drug: Seretide Diskus with charcoal