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

NCT ID: NCT01013454

Last Updated: 2009-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Smoking Cessation

Keywords

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varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Varenicline transdermal delivery system

Group Type EXPERIMENTAL

varenicline free base patch

Intervention Type 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

Interventions

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varenicline free base patch

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051119&StudyName=A%20Study%20Evaluating%20The%20Absorption%20Of%20Varenicline%20Into%20The%20Body%20From%20A%20Varenicline%20Patch%20Applied%20To%20The%20Skin

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3051119

Identifier Type: -

Identifier Source: org_study_id