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This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT010 | Experimental | PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations |
|
| PT009 | Experimental | PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations |
|
| Symbicort Turbohaler | Active Comparator | Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT010 | Drug | PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety of PT010, PT009 and Symbicort Turbohaler | The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram | 12 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler | 12 Hour post dose | |
| ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler | 12 Hour post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadwick Orevillo | Pearl Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33152467 | Derived | Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2. | |
| 29901860 | Derived |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| PT009 | Drug | PT009 administered as 2 inhalations |
|
|
| Symbicort Turbohaler | Drug | Symbicort Turbohaler taken as 2 inhalations |
|
|
| ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler | 12 Hour post dose |
| ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| Maes A, DePetrillo P, Siddiqui S, Reisner C, Dorinsky P. Pharmacokinetics of Co-Suspension Delivery Technology Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate (BGF MDI) and Budesonide/Formoterol Fumarate Dihydrate (BFF MDI) Fixed-Dose Combinations Compared With an Active Control: A Phase 1, Randomized, Single-Dose, Crossover Study in Healthy Adults. Clin Pharmacol Drug Dev. 2019 Feb;8(2):223-233. doi: 10.1002/cpdd.585. Epub 2018 Jun 14. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |