This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
Sandoz Investigational Site
Toronto, Ontario, Canada
AUCt
The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method.
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
AUCinf
The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration.
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Cmax
Maximum measured analyte concentration over the sampling period.
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Tmax
Time of the maximum measured analyte concentration over the sampling period.
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Kel
The apparent first-order elimination rate constant
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
Thalf
The apparent elimination half-life
Time frame: From time 0 hours (prior to dosing), up to 48 or 72 hours post dose
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