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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

An Open Label, Randomized, Three-treatment, Three-period, Crossover, Single Dose Study, to Investigate Drug-drug Interaction and Relative Bioavailability Between the Fixed Dose Combination Azelastine Hydrochloride / Beclomethasone Dipropionate (140/100 μg Azelastine Hydrochloride / Beclomethasone Dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the Test Vehicle, and the Commercially Available Product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in Healthy Subjects Under Fasting Conditions

NCT04817800•Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

An open label, randomized, three-treatment, three-period, crossover, single dose study, to investigate drug-drug interaction and relative bioavailability between the fixed dose combination Azelastine hydrochloride / Beclomethasone dipropionate (140/100 μg Azelastine hydrochloride / Beclomethasone dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the test vehicle, and the commercially available product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in healthy subjects under fasting conditions.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
•(18.5 - 30.0 Kg/m2).
•The subject is willing to undergo the necessary pre- \& post- medical examinations set by this
•study.
•The results of medical history, vital signs, physical examination \& conducted medical laboratory
•tests are normal as determined by the clinical investigator.
•The subject tested negative for hepatitis (HBsAg, HCVAb) viruses and human immunodeficiency
•virus (HIVAb).
•There is no evidence of psychiatric disorder, antagonistic personality and poor motivation,
+7 more criteria

Exclusion Criteria

•The subject is smoker/ has positive cotinine test.
•The subject has suffered an acute illness one week before dosing.
•The subject has a history of or concurrent abuse of alcohol.
•The subject has a history of or concurrent abuse of illicit drugs.
•The subject has a history of hypersensitivity and/or contraindications to the study drug, its
•excipients and any related compounds.
•The subject has been hospitalized within three months before the study or during the study.
•The subject is vegetarian.
•The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days
•before dosing and until 23 hours after dosing in all study periods.
+16 more criteria

Locations (1)

ACDIMA Biocenter

Amman, Jordan

Key Dates

Start Date

March 25, 2021

Primary Completion Date

April 10, 2021

Completion Date

April 10, 2021

Last Updated

December 13, 2023

Enrollment

ACTUAL participants

Conditions

Seasonal Allergic Rhinitis

Interventions

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

DRUG

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

NCT06837233

Seasonal Allergic Rhinitis

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COMPLETEDPHASE1

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

NCT03570957

Seasonal Allergic Rhinitis

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COMPLETEDPHASE3

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis