The primary objective is to assess the effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i.e. FLU alone in the MP29-02 vehicle; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of FLU when administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product, Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP); To compare the effects of AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½); To assess adverse events.
This study will enrol healthy subjects. It is considered that study results are more discriminative in healthy subjects than in rhinitis patients as there are no interferences by varying rhinitis symptoms and respective differences in the status of the nasal mucosa regarding the 3 study periods. The time schedule for serum sampling (pre-dose and 8, 15, 30, 45 min, 1, 1¼, 1½, 2, 2½, 3, 4, 6, 8, 12, and 24 h p.a., time refer to the end of the second spray into the second nostril of each administration) is derived from previous bioavailability studies assuming a mean tmax of 1 h p.a. \[P5\] and a mean t1/2 of 3 h \[L9\]. Sampling times are expected to cover an AUC0-tlast above 80% of the total AUC of fluticasone propionate (bioanalytical detection method with a LLOQ of 0.5 pg/mL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray (= US formulation as used in pivotal studies)
REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies)
COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product)
ClinPharmCologne
Cologne, North Rhine-Westphalia, Germany
Effect of azelastine hydrochloride on the relative bioavailability of fluticasone
Effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i.e. FLU alone in the MP29-02 vehicle; REF).
Time frame: up to 24 h post application
Relative bioavailability
Relative bioavailability (AUC0-∞) of FLU when administered either as fixed AZE-FLU combination product (TEST) or as marketed FLU product, Fluticasone Propionate Nasal Spray, Roxane Laboratories (COMP)
Time frame: up to 24 h post application
Effects of AZE on other pharmacokinetic parameters
Effects of AZE on other pharmacokinetic parameters of FLU (AUC0 tlast, CL/f, Cmax, tmax, t½)
Time frame: up to 24 h post application
Adverse Events
Adverse Events
Time frame: At and between treatment periods
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