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

NCT06180083 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-12-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Hakan Gürpınar · Humanis Saglık

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-04-26
Completion
2023-07-05

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180083 on ClinicalTrials.gov