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OpenTrials
Completed

NCT Number: NCT01013454

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

This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, Caucasian, male, adult light to regular smokers

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

Treatment and study plan

varenicline free base patch

Drug

varenicline transdermal delivery system (6.0 mg payload [drug amount loaded in each patch]) will be applied to the upper back over a single 24 hour period

Primary outcomes

  1. Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit

    Time frame: 8 days

Secondary outcomes

  1. Evaluation of adverse events (including skin irritation)

    Time frame: 8 days

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2009
Registry last updated
Dec 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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