NCT06180083

Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray

Single Dose Bioequivalence Study of Azelastine Hydrochloride/Fluticasone Propionate 137microgram/50 Microgram Nasal Spray and DYMISTA Nasal Spray in Healthy Adult Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram in healthy adult human subjects.

Conditions

• Seasonal Allergic Rhinitis
• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Azelastine Hydrochloride/ Fluticasone propionate nasal spray	A single dose \[four sprays (two sprays in each nostril)\] of Azelastine HCL/ Fluticasone Propionate 137 mcg/50 mcg Nasal Spray
DRUG	'DYMISTA' NASAL SPRAY	A single dose \[four sprays (two sprays in each nostril)\] of 'DYMISTA' (AZELASTINE HYDROCHLORIDE/ FLUTICASONE PROPIONATE) NASAL SPRAY 137 Microgram/50 Microgram

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-04-26
• Completion: 2023-07-05
• First posted: 2023-12-22
• Last updated: 2023-12-28

Locations

1 site across 1 country: India