An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
NCT ID: NCT00731562
Last Updated: 2010-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2008-07-31
2008-09-30
Brief Summary
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2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Varenicline Controlled Release, Fasted
Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
Varenicline Controlled Release, Fed
Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
Interventions
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Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
Varenicline Tartrate Controlled Release
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
Eligibility Criteria
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Inclusion Criteria
* 18 to 55 years of age
Exclusion Criteria
* Illegal drug use
* Pregnant or nursing females
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
East Grand Forks, Minnesota, United States
Pfizer Investigational Site
Fargo, North Dakota, United States
Countries
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Related Links
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Other Identifiers
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A3051088
Identifier Type: -
Identifier Source: org_study_id
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