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Completed

NCT Number: NCT00731562

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

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.

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Key information

Conditions

Pharmacokinetics Behavior Bioavailability Health Behavior Smoking Cessation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, East Grand Forks, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline Tartrate Controlled Release

Drug

A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions

Primary outcomes

  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 outcomes

  1. Safety measures including adverse events

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 11, 2008
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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