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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mometasone + Azelastine, then Mometasone Furoate, then Azelastine Hydrochloride
|
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
|
| Experimental: Mometasone Furoate, then Azelastine Hydrochloride, then Mometasone + Azelastine
|
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
|
| Experimental: Azelastine Hydrochloride, then Mometasone + Azelastine, then Mometasone Furoate
|
Drug: Mometasone + Azelastine
Mometasone + Azelastine, 50 μg/140 μg (per actuation) liquid, nasal spray, two actuations administered in each nostril
Drug: Mometasone Furoate
Mometasone Furoate 50 μg (per actuation) nasal spray, two actuations administered in each nostril
Drug: Azelastine Hydrochloride
Azelastine Hydrochloride 140 μg (per actuation) nasal spray, two actuations administered in each nostril
|
Outcome Measures
Primary Outcome Measures
- AUCt [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
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.
- AUCinf [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
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.
- Cmax [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
Maximum measured analyte concentration over the sampling period.
- Tmax [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
Time of the maximum measured analyte concentration over the sampling period.
- Kel [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
The apparent first-order elimination rate constant
- Thalf [From time 0 hours (prior to dosing), up to 48 or 72 hours post dose]
The apparent elimination half-life
Eligibility Criteria
Criteria
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.
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Unable to tolerate direct venipuncture.
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Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
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Positive test result for urine drugs of abuse or urine cotinine.
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Presence of nostril or septum piercing.
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Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
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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.
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Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
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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.
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Received any type of live vaccine within 30 days prior to drug administration.
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Use of medication within 30 days prior to drug administration.
-
On a special diet within 30 days prior to drug administration.
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Have had a tattoo or body piercing within 30 days prior to drug administration.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sandoz Investigational Site | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Sandoz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAN-0791
- 2023-000362-34