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

NCT04817800 | Completed Phase 1

• 1 other identifier: 980-2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

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 Spray; 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate); RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• (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,
• emotional or intellectual problems likely to limit the validity of consent to participate in the study
• or limit the ability to comply with protocol requirements.
• The subject is able to understand and willing to sign the informed consent form.
• For female subjects: negative pregnancy test and the woman is using two reliable contraception
• methods \& should be non-lactating.

You may not qualify if:

• 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.
• The subject has taken a prescription medication within two weeks or even an over the counter
• product (OTC) within one week before dosing in each study period and any time during the study,
• unless otherwise judged acceptable by the clinical investigator.
• The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before
• first dosing and any time during the study.

Sponsors & Collaborators

• Humanis Saglık Anonim Sirketi: lead

Study Sites (1)

ACDIMA Biocenter

Amman, Jordan

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

azelastine; Beclomethasone; Nasal Sprays

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hakan Gürpınar

  Humanis Saglık

  STUDY DIRECTOR

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: March 19, 2021
• First Posted: March 26, 2021
• Study Start: March 25, 2021
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

JO (1)