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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.

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Fargo, North Dakota, 58104 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy adult smokers

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or
neurologic disease

- Illegal drug usage

NCT00661765
Pfizer
Completed
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.

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Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers
Brief Summary
  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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: varenicline tartrate
    Single dose of 2.0 mg oral Chantix (varenicline) immediate release tablet formulation
    Other Name: varenicline, Chantix, Champix
  • Drug: varenicline free base
    A single 2.0 mg dose of varenicline transdermal delivery system applied to the skin for a 24 hour period.
    Other Name: varenicline
Study Arms  ICMJE
  • Active Comparator: Chantix immediate release tablet formulation
    Intervention: Drug: varenicline tartrate
  • Experimental: Varenicline transdermal delivery system
    Intervention: Drug: varenicline free base
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2008)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion DateJune 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy adult smokers

Exclusion Criteria:

  • Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
  • Illegal drug usage
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661765
Other Study ID Numbers  ICMJE A3051071
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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