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.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00661765
First received: April 14, 2008
Last updated: April 22, 2009
Last verified: April 2009
  Purpose
  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®).

Condition Intervention Phase
Smoking Cessation
Drug: varenicline tartrate
Drug: varenicline free base
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


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 ]

Enrollment: 18
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chantix immediate release tablet formulation Drug: varenicline tartrate
Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
Other Name: varenicline, Chantix, Champix
Experimental: Varenicline transdermal delivery system Drug: varenicline free base
A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
Other Name: varenicline

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult smokers

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00661765     History of Changes
Other Study ID Numbers: A3051071
Study First Received: April 14, 2008
Last Updated: April 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
varenicline bioavailability transdermal smoking cessation

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014