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 with charcoal
- Conditions
- Asthma
- Sponsor
- Orion Corporation, Orion Pharma
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Cmax of plasma salmeterol and fluticasone propionate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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, 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
Arms & Interventions
Salmeterol/fluticasone Easyhaler with charcoal
Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration
Intervention: Salmeterol/fluticasone Easyhaler with charcoal
Salmeterol/fluticasone Easyhaler
single dose of Salmeterol/fluticasone Easyhaler
Intervention: Salmeterol/fluticasone Easyhaler
Seretide Diskus
Single dose of Seretide Diskus
Intervention: Seretide Diskus
Seretide Diskus with charcoal
Single dose of Seretide Diskus with concomitant charcoal administration
Intervention: Seretide Diskus with charcoal
Outcomes
Primary Outcomes
Cmax of plasma salmeterol and fluticasone propionate
Time Frame: 0 hour to 34 hours after study treatment administration
AUCt of plasma salmeterol and fluticasone propionate
Time Frame: 0 hour to 34 hours after study treatment administration