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
Overview
- Phase
- Phase 1
- Intervention
- Salmeterol/fluticasone Easyhaler
- Conditions
- Asthma
- Sponsor
- Orion Corporation, Orion Pharma
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Cmax of plasma salmeterol and fluticasone propionate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Salmeterol/fluticasone Easyhaler
Single dose of Salmeterol/fluticasone Easyhaler
Intervention: Salmeterol/fluticasone Easyhaler
Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules)
Intervention: Salmeterol/fluticasone Easyhaler with charcoal
Seretide Diskus
Single dose of Seretide Diskus
Intervention: Seretide Diskus
Seretide Diskus with charcoal
Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules)
Intervention: Seretide Diskus with charcoal
Outcomes
Primary Outcomes
Cmax of plasma salmeterol and fluticasone propionate
Time Frame: within 34 h
AUCt of plasma salmeterol and fluticasone propionate
Time Frame: 34 h