Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

Maximum observed plasma concentration (Cmax) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
23 hours
area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to the last sampling time with quantifiable concentrations (AUC0-t) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
23 hours
AUC from time zero to infinity (AUC0-∞) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
23 hours

Secondary Outcomes (4)

Obtaining the Tmax (Time to reach maximum concentration)
23 hours
Blood pressure (safety and tolerability)
At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Pulse (safety and tolerability)
At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Temperature (safety and tolerability)
At 1 hour pre-dosing and 2, 6, 10, 14, 18, 22 and 23 hours post dosing,

Study Arms (3)

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

EXPERIMENTAL

Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

100 μg Beclomethasone dipropionate, Nasal Spray

EXPERIMENTAL

Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

ACTIVE COMPARATOR

Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

Interventions

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)Drug

It will be nasaly administered

Also known as: 100 μg Beclomethasone dipropionate, Nasal Spray, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

100 μg Beclomethasone dipropionate, Nasal Spray140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

The subject is Caucasian \& aged between eighteen \& fifty years (18 - 50), both inclusive.
The subject is within the limits for his height \& weight as defined by the body mass index range

Sponsors & Collaborators

Humanis Saglık Anonim Sirketi
Industrylead

Study Sites (1)

ACDIMA Biocenter

Amman, Jordan

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastineBeclomethasoneNasal Sprays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Study Officials

Hakan Gürpınar
Humanis Saglık
STUDY DIRECTOR

To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (3)

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

100 μg Beclomethasone dipropionate, Nasal Spray

RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (3)

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

100 μg Beclomethasone dipropionate, Nasal Spray

RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations