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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
| 3M | INDUSTRY |
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The purpose of this study is to compare the absorption of three different inhalation products with the reference products in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 3 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 8 hours post-dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test product A | Experimental | tiotropium |
|
| test product B | Experimental | tiotropium |
|
| test product C | Experimental | tiotropium |
|
| Commercial product D | Active Comparator | tiotropium |
|
| commercial product E | Active Comparator | tiotropium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | 4 inhalations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | noncompartmental analysis | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | reported adverse events | 8 hours |
| Area Under the Plasma Concentration vs Time Curve (AUC) | trapezoidal rule | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pui Leung, MD | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Ruddington | Nottingham | NG11 6JS | United Kingdom |
summary data will be available
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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 |