A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation

Treatments: Drug: varenicline free base; Drug: varenicline tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661765

A3051071

Details and patient eligibility

About

1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®).
2. To evaluate the adhesion of the varenicline Formulation A patch.
3. To evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (CHANTIX®).

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adult smokers

Exclusion criteria

• Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
• Illegal drug usage

Trial design

18 participants in 2 patient groups

Chantix immediate release tablet formulation

Active Comparator group

Treatment:

Drug: varenicline tartrate

Varenicline transdermal delivery system

Experimental group

Treatment:

Drug: varenicline free base