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

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ClinicalTrials.gov Identifier: NCT00731562
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Bioavailability Smoking Cessation Drug: Varenicline Tartrate Controlled Release Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Varenicline Controlled Release, Fasted Drug: Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions

Experimental: Varenicline Controlled Release, Fed Drug: Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions




Primary Outcome Measures :
  1. 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 ]
  2. Maximum plasma concentration of varenicline [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Safety measures including adverse events [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731562


Locations
United States, Minnesota
Pfizer Investigational Site
East Grand Forks, Minnesota, United States, 56721
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00731562     History of Changes
Other Study ID Numbers: A3051088
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by Pfizer:
food, varenicline, pharmacokinetics, bioavailability

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs