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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and two reference inhalation products according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 48 hours post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 Tiotropium | Experimental | 4 inhalations |
|
| Test Product 2 Tiotropium | Experimental | 4 inhalations |
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| Test Product 3 Tiotropium | Experimental | 4 inhalations |
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| Reference Tiotropium | Active Comparator | 2 inhalations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum plasma concentration | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Sessions, PhD | 3M | Study Chair |
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results will be shared through publication
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |