Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory blinded
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
18
BECRO Clinical Facility
Larissa, Thessaly, Greece
Cmax for Fluticasone Propionate (FP)
Maximum plasma concentration, it is read directly from the raw data
Time frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
Cmax for Salmeterol
Maximum plasma concentration, it is read directly from the raw data
Time frame: Time Frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
AUC(0-t) for Fluticasone Propionste (FP)
Area under the plasma concentration curve from time 0 to the last measured concentration at time t
Time frame: Time Frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
AUC(0-t) for Salmeterol
Area under the plasma concentration curve from time 0 to the last measured concentration at time t
Time frame: Time Frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
AUC0-∞
Area under the plasma concentration-time curve extrapolated to infinity AUC0-∞=AUC0-t+Ct/λz. Ct is the last measured concentration and λz is the apparent terminal elimination rate constant
Time frame: up to 36 hours post-administration
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Tmax
Time until Cmax is reached, it is read directly from the observed concentrations
Time frame: up to 36 hours post-administration
t1/2
Plasma concentration halflife, it is calculated from the ratio 0.693/λZ
Time frame: up to 36 hours post-administration
λz
Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis
Time frame: up to 36 hours post-administration
Residual Area
\[AUC(0-∞)-AUC(0-t)\]/AUC(0-∞)\]
Time frame: up to 36 hours post-administration