Asthma
Conditions
Brief summary
The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
Interventions
Seretide Diskus 50/250 µg/dose
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion Criteria: 1. Written informed consent (IC) obtained. 2. Males and females, 18-60 (inclusive) years of age. 3. Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2). 4. Weight at least 50 kg. Main
Exclusion criteria
1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease. 2. Any condition requiring regular concomitant treatment. 3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. 4. Known hypersensitivity to the active substance(s) or the lactose. 5. Pregnant or lactating females and females of childbearing potential not using proper contraception. 6. Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration. 7. Administration of another investigational medicinal product within 90 days prior to first study treatment administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Truncated area under the plasma concentration versus time curve (AUC) of salmeterol | 0-30 minutes after dosing | AUC from time zero to 30 min after study treatment administration |
| Peak plasma concentration (Cmax) of salmeterol | between 0-34 hours after dosing | Cmax of salmeterol |
| Peak plasma concentration (Cmax) of fluticasone propionate | between 0-34 hours after dosing | Cmax of fluticasone propionate |
| Area under the plasma concentration versus time curve (AUC) of salmeterol | 0-34 hours after dosing | AUC from time zero to the last sample with the quantifiable concentration |
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate | 0-34 hours after dosing | AUC from time zero to the last sample with the quantifiable concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to reach the maximum concentration (tmax) of fluticasone propionate | 0-34 hours after dosing | tmax of fluticasone propionate |
| The terminal elimination half-life (t1/2) of salmeterol | 0-34 hours after dosing | t1/2 of salmeterol |
| The terminal elimination half-life (t1/2) of fluticasone propionate | 0-34 hours after dosing | t1/2 of fluticasone propionate |
| Area under the plasma concentration versus time curve (AUC) of salmeterol | 0-34 hours after dosing and extrapolation | AUC from time zero to infinity |
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate | 0-34 hours after dosing and extrapolation | AUC from time zero to infinity |
| The time to reach the maximum concentration (tmax) of salmeterol | 0-34 hours after dosing | tmax of salmeterol |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | through study completion, an average of 6 weeks | Adverse events |
Countries
Finland
Outcome results
None listed