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This study will evaluate the steady-state pharmacokinetics, safety and tolerability of a varenicline patch applied once daily to the skin for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline free base patch | Drug | varenicline transdermal delivery system (12.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC24); observed maximum plasma concentration (Cmax) in a given dosing interval and time of maximum plasma concentration (Tmax) | Days 1, 7 and 14 | |
| Observed accumulation ratio (Rac) | Days 7 and 14 | |
| Observed minimum plasma concentration (Cmin) in a given dosing interval, and peak: trough fluctuation (PTF) | Days 7 and 14 | |
| Terminal half life (t1/2) | Day 14-Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Dermal rating scores (as measured by the Rating Scale for Assessment of Application Site Dermal-Erythema, Edema and Irritation) | Days 1-14 (24 hpd); Days 1, 7-8 (1 and 12 hpd); Day 14 (1,6,12,24,48,72,96 and 120 hpd) | |
| VAS scores for nausea (using a Visual Analog Scale) |
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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 | Fargo | North Dakota | 58104 | 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 | varenicline transdermal delivery system (18.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days |
|
| placebo patch | Drug | Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days |
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| varenicline free base patch | Drug | varenicline transdermal delivery system (24.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days |
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| placebo patch | Drug | Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days |
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| varenicline free base patch | Drug | 2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days |
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| placebo patch | Drug | Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days |
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| Days 1-19 (daily) |
| Daily adhesion score (as measured by the Rating Scale for Adhesion) | Days 1-14 (12 and 24 hpd);Days 1, 7 and 14 (1 and 6 hpd) |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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