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varenicline free base patch · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Varenicline transdermal delivery system | EXPERIMENTAL | - |
| Varenicline free base solution | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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 |
| placebo patch | DRUG | Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days |
| 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 |
Inclusion Criteria: * Healthy * male or female * adult cigarette smokers of any race Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including d...
Varenicline free base patch is an investigational small molecule being developed for smoking cessation. It is a transdermal patch formulation of varenicline, a medication used to help people stop smoking. The patch is designed to deliver varenicline through the skin, and it is currently in Phase 1 clinical development.
Varenicline free base patch is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the absorption of varenicline from the patch applied to the skin.
Varenicline free base patch is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 1 trials have been completed, with a total of 69 participants enrolled across studies in the United States and Belgium.
Varenicline free base patch has been studied in three completed Phase 1 trials: NCT00774605, NCT01013454, and NCT01234142. These trials evaluated the absorption of varenicline from the patch into the body, including a 14-day once-daily application study. All trials enrolled healthy volunteers.
Varenicline free base patch works by delivering varenicline, a medication that acts on nicotine receptors in the brain, through the skin. By providing a steady release of varenicline, the patch aims to help reduce cravings and withdrawal symptoms associated with smoking cessation.