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To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.
Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline free base solution | Experimental |
| |
| Varenicline transdermal delivery system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline free base solution | Drug | A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of adverse events (including skin irritation) | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Varenicline free base patch | Drug | A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period |
|
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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