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.

A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661765

Enrollment

Registered

2008-04-18

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2009-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

varenicline bioavailability transdermal smoking cessation

Brief summary

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®).

Interventions

DRUGvarenicline tartrate

Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation

DRUGvarenicline free base

A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy adult smokers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin)	24 hours per Arm
Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system)	6 days per Arm
Pharmacokinetic endpoints: plasma varenicline area under the curve (AUClast and AUCinf), maximum plasma concentration (Cmax), terminal half-life (t 1/2) and time of maximum plasma concentration (Tmax)	6 days per Arm

Secondary

Measure	Time frame
Assessment of Adhesidue/Cold Flow Assessment (assesses extent of adhesive residue which remains on the skin at application site as well as the adhesive flow beyond the application site border	24 hours per Arm
Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs	6 days per Arm

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026