Clinical trial NCT04817800: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Humanis Saglık Anonim Sirketi
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
timeFrame: 23 hours
measure: 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
timeFrame: 23 hours
measure: AUC from time zero to infinity (AUC0-∞) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
timeFrame: 23 hours
Secondary outcomes:
measure: Obtaining the Tmax (Time to reach maximum concentration)
timeFrame: 23 hours
measure: Blood pressure (safety and tolerability)
timeFrame: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
measure: Pulse (safety and tolerability)
timeFrame: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
measure: Temperature (safety and tolerability)
timeFrame: At 1 hour pre-dosing and 2, 6, 10, 14, 18, 22 and 23 hours post dosing,
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: ACDIMA Biocenter
Study officials:
affiliation: Humanis Saglık
name: Hakan Gürpınar
role: STUDY_DIRECTOR
References: