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

NCT ID: NCT00774605

Last Updated: 2009-01-26

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

2008-12-31

Study Completion Date

2008-12-31

Brief Summary

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To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.

Detailed Description

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

Conditions

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Smoking Cessation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Varenicline free base solution

Group Type EXPERIMENTAL

Varenicline free base solution

Intervention Type DRUG

A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period

Varenicline transdermal delivery system

Group Type EXPERIMENTAL

Varenicline free base patch

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy, adult, male smokers

Exclusion Criteria

* significant medical illness
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

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A3051118

Identifier Type: -

Identifier Source: org_study_id

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