An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation

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NCT00731562

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Study Location
Pfizer Investigational Site
East Grand Forks, Minnesota, 56721, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics, Bioavailability, 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 male or female adult smokers

- 18 to 55 years of age

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


- Sensitivity to varenicline


- Illegal drug use


- Pregnant or nursing females

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Pharmacokinetics, Bioavailability, Smoking CessationAn Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
NCT00731562
  1. East Grand Forks, Minnesota
  2. Fargo, North Dakota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
Official Title  ICMJE Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers
Brief Summary
  1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
  2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.
Detailed Description Not 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
  • Pharmacokinetics
  • Bioavailability
  • Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline Tartrate Controlled Release
    A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
  • Drug: Varenicline Tartrate Controlled Release
    A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
Study Arms  ICMJE
  • Experimental: Varenicline Controlled Release, Fasted
    Intervention: Drug: Varenicline Tartrate Controlled Release
  • Experimental: Varenicline Controlled Release, Fed
    Intervention: Drug: Varenicline Tartrate Controlled Release
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: August 7, 2008)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female adult smokers
  • 18 to 55 years of age

Exclusion Criteria:

  • Sensitivity to varenicline
  • Illegal drug use
  • Pregnant or nursing females
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 NCT00731562
Other Study ID Numbers  ICMJE A3051088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP