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

980-2020

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.

2021-03-25

2021-04-10

2021-04-10

Completed

Early phase I

48

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

2023-12-13