Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02162485

3106009

Details and patient eligibility

About

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

Enrollment: 129 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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129 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 (Carbomix granules)

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 (Carbomix granules)

Treatment:

Drug: Seretide Diskus with charcoal