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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: varenicline free base patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01013454

A3051119

Details and patient eligibility

About

This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, Caucasian, male, adult light to regular smokers

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Varenicline transdermal delivery system

Experimental group

Treatment:

Drug: varenicline free base patch