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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004145-10 | EudraCT Number |
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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 two different inhalation products with the reference product in healthy volunteers.
Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. 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 |
|
| reference product | Active Comparator | tiotropium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium | Drug | four inhalations |
|
| Measure | Description | Time Frame |
|---|---|---|
| peak plasma concentration | measured by noncompartmental analysis | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | reported adverse events | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| area under the plasma concentration vs. time curve | measured by the trapezoidal rule | 8 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pui Leung, MD | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Ruddington | Nottingham | NG11 6JS | United Kingdom |
will share summary data
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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 |