Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.

Official Title
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An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to 24 Years of Age) With Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Mometasone + Azelastine
* Drug: Mometasone Furoate
* Drug: Azelastine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis. Willing to use acceptable, effective methods of contraception. Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure. Exclusion Criteria: Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity. Unable to tolerate direct venipuncture. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. Positive test result for urine drugs of abuse or urine cotinine. Presence of nostril or septum piercing. Use of tobacco or nicotine-containing products within 6 months prior to drug administration. Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration. Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL). Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results. Received any type of live vaccine within 30 days prior to drug administration. Use of medication within 30 days prior to drug administration. On a special diet within 30 days prior to drug administration. Have had a tattoo or body piercing within 30 days prior to drug administration.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride<br> | Drug: Mometasone + Azelastine<br>* Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril<br>Drug: Mometasone Furoate<br>* Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril<br>Drug: Azelastine Hydrochloride<br>* Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril<br>|
| Experimental: Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine<br> | Drug: Mometasone + Azelastine<br>* Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril<br>Drug: Mometasone Furoate<br>* Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril<br>Drug: Azelastine Hydrochloride<br>* Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril<br>|
| Experimental: Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate<br> | Drug: Mometasone + Azelastine<br>* Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril<br>Drug: Mometasone Furoate<br>* Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril<br>Drug: Azelastine Hydrochloride<br>* Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear up/log down variant of the trapezoidal method. | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose | 
| AUCinf | The area under the analyte concentration versus time curve from time zero to infinity. AUCinf = AUCt + Ct/Kel, where Ct is the last measurable analyte concentration. | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose | 
| Cmax | Maximum measured analyte concentration over the sampling period. | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose | 
| Tmax | Time of the maximum measured analyte concentration over the sampling period. | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose | 
| Kel | The apparent first-order elimination rate constant | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose | 
| Thalf | The apparent elimination half-life | From time 0 hours (prior to dosing), up to 48 or 72 hours post dose |