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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00774605
First Posted: October 17, 2008
Last Update Posted: January 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Condition Intervention Phase
Smoking Cessation Drug: Varenicline free base solution Drug: Varenicline free base patch Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf) [ Time Frame: 8 days ]

Secondary Outcome Measures:
  • Evaluation of adverse events (including skin irritation) [ Time Frame: 8 days ]

Enrollment: 12
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline free base solution Drug: Varenicline free base solution
A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period
Experimental: Varenicline transdermal delivery system Drug: Varenicline free base patch
A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period

Detailed Description:
Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, adult, male smokers

Exclusion Criteria:

  • significant medical illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774605


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00774605     History of Changes
Other Study ID Numbers: A3051118
First Submitted: October 16, 2008
First Posted: October 17, 2008
Last Update Posted: January 26, 2009
Last Verified: January 2009

Keywords provided by Pfizer:
percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch

Additional relevant MeSH terms:
Pharmaceutical Solutions
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs