Trials Sponsors Conditions Drugs Pricing

Conditions

Perennial Allergic Rhinitis Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

Maximum measured plasma concentration(Cmax)
The 90% confidence interval of the relative mean (geometric least square mean) of the test to reference product for Ln-transformed Pharmacokinetic parameters Cmax was to be within 80.00% to 125.00%
120 hours
Area under the plasma concentration versus time curve from the zero time point to the last quantifiable concentration (AUCt)
The 90% confidence intervals of the relative mean (Geometric least square mean) of the test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%. bioequivalence.
120 hours

Secondary Outcomes (2)

Area under the plasma concentration versus time curve from time zero to infinity (AUCi)
120 hours
Time of the maximum measured plasma concentration (Tmax)
120 hours

Study Arms (2)

Azelastine Hydrochloride/ Fluticasone propionate nasal spray

EXPERIMENTAL

Azelastine Hydrochloride/ Fluticasone propionate 137 microgram/50 microgram nasal spray

Drug: Azelastine Hydrochloride/ Fluticasone propionate nasal sprayDrug: 'DYMISTA' NASAL SPRAY

'DYMISTA' Nasal Spray

ACTIVE COMPARATOR

'DYMISTA' (Azelastine Hydrochloride/ Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram

Drug: Azelastine Hydrochloride/ Fluticasone propionate nasal sprayDrug: 'DYMISTA' NASAL SPRAY

Interventions

Azelastine Hydrochloride/ Fluticasone propionate nasal sprayDrug

A single dose \[four sprays (two sprays in each nostril)\] of Azelastine HCL/ Fluticasone Propionate 137 mcg/50 mcg Nasal Spray

'DYMISTA' Nasal SprayAzelastine Hydrochloride/ Fluticasone propionate nasal spray

'DYMISTA' NASAL SPRAYDrug

A single dose \[four sprays (two sprays in each nostril)\] of 'DYMISTA' (AZELASTINE HYDROCHLORIDE/ FLUTICASONE PROPIONATE) NASAL SPRAY 137 Microgram/50 Microgram

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Azelastine Hydrochloride/ Fluticasone propionate nasal spray
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age: 18 to 45 years old, both inclusive.
Gender: Male and/or non-pregnant, non-lactating female.

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 382210, India

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

Interventions

azelastine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Hakan Gürpınar
Humanis Saglık
STUDY DIRECTOR

Enrollment

56 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2023

First Posted

December 22, 2023

Study Start

March 24, 2023

Actual (reported)

You may not qualify if:

History of allergic responses to Azelastine and Fluticasone Propionate or other related drugs, or any of its formulation ingredients.
Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG, nasal examination \[examination include (1) external nose but not limited to size and shape, obvious swellings or deformity, scars or skin changes and redness or discharge and (2) nasal cavity for but not limited to nasal septum, turbinates, entire nasal cavity for rhinitis, oedematous and inflamed mucosa, polyps or any other abnormalities and presence of any foreign bodies\], Peak Nasal Inspiratory Flow measurement, chest X-ray recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
History or presence of bronchial asthma.
Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
History of difficulty with donating blood or difficulty in accessibility of veins.
A positive hepatitis screen (includes subtypes B \& C).
A positive test result for HIV antibody and / or syphilis (RPR).
Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication or who had participated in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the first dose of study medication, whichever was greater.
Volunteers who had donated blood within 80 days (excluding volume drawn at screening for this study) prior to first dose of study medication.
Intolerance to venipuncture
Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, contraindicated the volunteer's participation in this study.
+13 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Azelastine Hydrochloride/ Fluticasone propionate nasal spray

'DYMISTA' Nasal Spray

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

Azelastine Hydrochloride/ Fluticasone propionate nasal spray

'DYMISTA' Nasal Spray

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations