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

• Status: Completed
• Trial end date: 2021-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmactive Ilac Sanayi ve Tic A.S.
• Treatments: Azelastine; Beclomethasone

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.