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Status:

COMPLETED

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

Lead Sponsor:

Humanis Saglık Anonim Sirketi

Conditions:

Seasonal Allergic Rhinitis

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 25 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 10 2021

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT04817800

Start Date

March 25 2021

End Date

April 10 2021

Last Update

December 13 2023

Active Locations (1)

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ACDIMA Biocenter

Amman, Jordan