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.

NCT ID: NCT00661765

Last Updated: 2009-04-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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®).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chantix immediate release tablet formulation

Group Type ACTIVE_COMPARATOR

varenicline tartrate

Intervention Type DRUG

Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation

Varenicline transdermal delivery system

Group Type EXPERIMENTAL

varenicline free base

Intervention Type DRUG

A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

varenicline tartrate

Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation

Intervention Type DRUG

varenicline free base

A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

varenicline, Chantix, Champix varenicline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy adult smokers

Exclusion Criteria

* Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
* Illegal drug usage
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Fargo, North Dakota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A3051071

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Varenicline for Light Smokers
NCT01639560 COMPLETED PHASE4
Feasibility of Treatment for Vaping Cessation
NCT04317300 WITHDRAWN EARLY_PHASE1
Nicotine Patch Bioequivalence Study
NCT01658202 COMPLETED PHASE1
Relapse Prevention With Varenicline
NCT00944554 COMPLETED PHASE4
Varenicline Light Smoking Pilot
NCT04089982 COMPLETED PHASE4
Chantix & Bupropion for Smoking Cessation
NCT00587769 COMPLETED PHASE3