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The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDP HFA Nasal Aerosol 80 mcg/d | Experimental | single dose, intranasal aerosol |
|
| BDP HFA Nasal Aerosol 320 mcg/d | Experimental | single dose, intranasal aerosol |
|
| BDP HFA Inhalation Aerosol 320 mcg/d | Active Comparator | single dose, orally inhaled aerosol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDP HFA Nasal Aerosol | Drug | BDP HFA Nasal 80mcg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics |
| 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics |
| 24 hours post dose |
| Safety and tolerability of BDP HFA nasal aerosol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry, PhD | Teva Global Respiratory Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22621776 | Derived | Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| BDP HFA Nasal Aerosol |
| Drug |
BDP HFA Nasal 320mcg |
|
| BDP HFA Inhalation Aerosol (QVAR) | Drug | BDP HFA Oral 320mcg |
|
Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study) |
| 24 hours post dose |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |