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. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00661765

Purpose

To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®).
To evaluate the adhesion of the varenicline Formulation A patch.
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®).

Condition	Intervention	Phase
Smoking Cessation	Drug: varenicline tartrate Drug: varenicline free base	Phase I

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin) [ Time Frame: 24 hours per Arm ] [ Designated as safety issue: No ]
Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system) [ Time Frame: 6 days per Arm ] [ Designated as safety issue: No ]
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) [ Time Frame: 6 days per Arm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 24 hours per Arm ] [ Designated as safety issue: No ]
Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs [ Time Frame: 6 days per Arm ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Chantix immediate release tablet formulation: Active Comparator	Drug: varenicline tartrate Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
Varenicline transdermal delivery system: Experimental	Drug: varenicline free base A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661765

Locations

United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051071
Study First Received:	April 14, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00661765
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

varenicline bioavailability transdermal smoking cessation

Study placed in the following topic categories:

Smoking

ClinicalTrials.gov processed this record on January 15, 2009