Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: salmeterol-fluticasone
- Registration Number
- NCT03238482
- Lead Sponsor
- Orion Corporation, Orion Pharma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Seretide Diskus salmeterol-fluticasone salmeterol-fluticasone 2 inhalations as a single dose Salmeterol/fluticasone Easyhaler, G salmeterol-fluticasone salmeterol-fluticasone 2 inhalations as a single dose Salmeterol/fluticasone Easyhaler, E salmeterol-fluticasone salmeterol-fluticasone 2 inhalations as a single dose Salmeterol/fluticasone Easyhaler, F salmeterol-fluticasone salmeterol-fluticasone 2 inhalations as a single dose
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of salmeterol between 0-34 hours after dosing Cmax of salmeterol
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 fluticasone propionate between 0-34 hours after dosing Cmax of fluticasone propionate
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
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
- Secondary Outcome Measures
Name Time Method The terminal elimination half-life (t1/2) of salmeterol 0-34 hours after dosing t1/2 of salmeterol
Area under the plasma concentration versus time curve (AUC) of salmeterol 0-34 hours after dosing and extrapolation AUC from time zero to infinity
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 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
The time to reach the maximum concentration (tmax) of fluticasone propionate 0-34 hours after dosing tmax of fluticasone propionate
Trial Locations
- Locations (1)
Clinical Pharmacology Unit, Orion Pharma
🇫🇮Espoo, Finland