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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users.
This will be an single-blind, multi-center, randomized, two-way crossover study, conducted in generally healthy, adult moist snuff users who will be randomly assigned to the order in which they will use two moist snuff study products (comparator product, test product). The study will evaluate pharmacokinetic (PK) measures for two moist snuff products in a 7-day confinement setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1805AA, 1805AB Use Group | Experimental | Use of product 1805AA exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AB exclusively for approximately 3 days prior to a PK assessment. |
|
| 1805AB, 1805AA Use Group | Experimental | Use of product 1805AB exclusively for approximately 3 days prior to a PK assessment, followed by use of product 1805AA exclusively for approximately 3 days prior to a PK assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1805AA | Other | A moist snuff product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCnic 0-240 | area under the baseline-adjusted nicotine concentration- versus-time curve from time zero to 240 minutes after the start of Investigational Product (IP) use | -5, -1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180, 210 and 240 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuel DeNoia, MD | ICON Clinical Research | Principal Investigator |
| Melanie Fein, MD | High Point Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States | ||
| ICON Clinical Research |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 1805AB |
| Other |
A moist snuff product |
|
| San Antonio |
| Texas |
| 78209 |
| United States |