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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 one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 | Experimental | tiotropium pMDI 2 inhalations |
|
| Test Product 2 | Experimental | tiotropium pMDI 2 inhalations |
|
| Test Product 3 | Experimental | tiotropium pMDI 2 inhalations |
|
| Test Product 4 | Experimental | tiotropium pMDI 2 inhalations |
|
| Commercial Product | Active Comparator | tiotropium Respimat 2 inhalations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium pMDI | Drug | inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | noncompartmental analysis | 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | reported adverse events | 24 hr |
| Area Under the Plasma Concentration vs Time Curve (AUC) | trapezoidal rule | 24 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Sessions, PhD | 3M | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3M Health Care | Loughborough | United Kingdom |
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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