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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Seretide Diskus 50/250 µg/dose
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
Clinical Pharmacology Unit, Orion Pharma
Espoo, Finland
Peak plasma concentration (Cmax) of salmeterol
Cmax of salmeterol
Time frame: between 0-34 hours after dosing
Peak plasma concentration (Cmax) of fluticasone propionate
Cmax of fluticasone propionate
Time frame: between 0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to the last sample with the quantifiable concentration
Time frame: 0-34 hours after dosing
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
AUC from time zero to the last sample with the quantifiable concentration
Time frame: 0-34 hours after dosing
Truncated area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to 30 min after study treatment administration
Time frame: 0-30 minutes after dosing
Area under the plasma concentration versus time curve (AUC) of salmeterol
AUC from time zero to infinity
Time frame: 0-34 hours after dosing and extrapolation
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
AUC from time zero to infinity
Time frame: 0-34 hours after dosing and extrapolation
The time to reach the maximum concentration (tmax) of salmeterol
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Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
tmax of salmeterol
Time frame: 0-34 hours after dosing
The time to reach the maximum concentration (tmax) of fluticasone propionate
tmax of fluticasone propionate
Time frame: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of salmeterol
t1/2 of salmeterol
Time frame: 0-34 hours after dosing
The terminal elimination half-life (t1/2) of fluticasone propionate
t1/2 of fluticasone propionate
Time frame: 0-34 hours after dosing