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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 May 11, 2018

FOR MORE INFORMATION
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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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.
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
  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®).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Smoking Cessation
  • 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
  • Active Comparator: Chantix immediate release tablet formulation
    Intervention: Drug: varenicline tartrate
  • Experimental: Varenicline transdermal delivery system
    Intervention: Drug: varenicline free base
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy adult smokers

Exclusion Criteria:

  • Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
  • Illegal drug usage
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00661765
A3051071
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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