Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray

Exclusion Criteria

• •History of allergic responses to Azelastine and Fluticasone Propionate or other related drugs, or any of its formulation ingredients.
• •Had significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination (clinical examination), laboratory evaluations, ECG, nasal examination \[examination include (1) external nose but not limited to size and shape, obvious swellings or deformity, scars or skin changes and redness or discharge and (2) nasal cavity for but not limited to nasal septum, turbinates, entire nasal cavity for rhinitis, oedematous and inflamed mucosa, polyps or any other abnormalities and presence of any foreign bodies\], Peak Nasal Inspiratory Flow measurement, chest X-ray recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)\].
• •Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
• •History or presence of bronchial asthma.
• •Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• •Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• •History of difficulty with donating blood or difficulty in accessibility of veins.
• •A positive hepatitis screen (includes subtypes B \& C).
• •A positive test result for HIV antibody and / or syphilis (RPR).
• •Volunteers who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication or who had participated in any clinical study (e.g. pharmacokinetics, bioavailability and bioequivalence studies) within the last 80 days prior to the first dose of study medication, whichever was greater.
• •Volunteers who had donated blood within 80 days (excluding volume drawn at screening for this study) prior to first dose of study medication.
• •Intolerance to venipuncture
• •Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, contraindicated the volunteer's participation in this study.
• •Institutionalized volunteers.
• •Used any prescribed medications (including ritonavir, cobicistat \& CNS depressants) within 14 days prior to the first dose of study medication.
• •Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
• •Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
• •Ingested of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
• •Ingested any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
• •Volunteer had any illness since screening visit.
• •Volunteer had any relevant disease including seasonal and perennial allergic rhinitis, asthma during screening.
• •Volunteer had clinically relevant structural nasal abnormalities including deviated nasal septum, and upper respiratory tract infection within two weeks prior to the start of the study.
• •Volunteer took steroids or any antihistamines or any drug related to allergic medication within 1 month prior to the dose of study medication.
• •Volunteer who was not ready to remove Nasal jewelry prior to enrollment in the study
• •Presence of nose piercings, which affected spray inhalation dosing and increase the deposition of the study drug in the nose.
• •Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye infection