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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00731562
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:

August 7, 2008
August 11, 2008
January 11, 2010
July 2008
September 2008   (Final data collection date for primary outcome measure)
  • Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf). [ Time Frame: 5 days ]
  • Maximum plasma concentration of varenicline [ Time Frame: 1 day ]
  • Maximum plasma concentration of varenicline [ Time Frame: 1 day ]
  • Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf). [ Time Frame: 5 days ]
Complete list of historical versions of study NCT00731562 on ClinicalTrials.gov Archive Site
Safety measures including adverse events [ Time Frame: 5 days ]
Same as current
Not Provided
Not Provided
 
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
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
  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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Pharmacokinetics
  • Bioavailability
  • Smoking Cessation
  • 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
  • Experimental: Varenicline Controlled Release, Fasted
    Intervention: Drug: Varenicline Tartrate Controlled Release
  • Experimental: Varenicline Controlled Release, Fed
    Intervention: Drug: Varenicline Tartrate Controlled Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
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
 
 
NCT00731562
A3051088
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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