A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin

Pfizer12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Smoking Cessation

Interventions

Varenicline free base solutionDRUG

A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period

Varenicline free base patchDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy, adult, male smokers Exclusion Criteria: * significant medical illness

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)

Time frame: 8 days

Secondary Outcomes

Evaluation of adverse events (including skin irritation)

Time frame: 8 days

Data from ClinicalTrials.gov

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