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

Humanis Saglık Anonim Sirketi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Seasonal Allergic Rhinitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04817800

980-2020

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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,
• 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.
• The subject has normal cardiovascular system and ECG recording.
• The subject kidney and liver (AST & ALT enzymes) functions tests are within normal range.

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.
• 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.
• The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and
• bioequivalence studies) within the last 80 days prior to the present study.
• The subject has donated blood within 80 days before first dosing.
• The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal,
• hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or
• psychiatric diseases.
• The subject has consumed drugs that may affect pharmacological or pharmacokinetic properties
• (ritonavir, cobicistat & CNS depressants) two weeks before dosing, during the study and two
• weeks after dosing.
• The subject has recent nose surgery or a history of chronic sinusitis, recent URTI and nasal septum
• deviation that may affect nasal mucosa integrity.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)

Experimental group

Treatment:

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

100 μg Beclomethasone dipropionate, Nasal Spray

Experimental group

Treatment:

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

RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)

Active Comparator group

Treatment:

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