Trials / Terminated
TerminatedNCT05887843
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
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 12 Years – 24 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-08
- Primary completion
- 2023-09-08
- Completion
- 2023-09-08
- First posted
- 2023-06-05
- Last updated
- 2023-09-28
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05887843. Inclusion in this directory is not an endorsement.