NCT01190852

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays

Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays Single-centre, Randomised, Open-label, Three-period, Six-sequence Cross-over Trial (William's Design)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to assess the effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF). The secondary objectives are to compare the relative bioavailability (AUC0-∞) of AZE when administered either as fixed AZE-FLU combination product (TEST) or as marketed AZE product Astelin® Nasal Spray (COMP); To compare the effects of FLU on other pharmacokinetic parameters of AZE (AUC0-tlast, CL/f, Cmax, tmax, t½); To assess adverse events.

Detailed description

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 plasma sampling (pre-dose and 15, 30 min, 1, 1½, 2, 2½, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 h p.a.; time refer to the end of the second spray into the second nostril of each administration) is derived from previous bioavailability study on the marketed product Astelin® Nasal Spray assuming a mean tmax of 2 to 3 h p.a. and a mean t1/2 of 22 h \[L7\]. Sampling times are expected to cover an AUC0-tlast above 80% of the total AUC of azelastine hydrochloride (bioanalytical detection method with a LLOQ of 2 pg/mL).

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine, Fluticasone	TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray
DRUG	Azelastine mono	REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)
DRUG	Azelastine	COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-08-30
• Last updated: 2022-02-07

Locations

1 site across 1 country: Germany