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

January 7, 2010 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • East Grand Forks, Minnesota, United States, 56721
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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
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, Fed
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 days
Maximum plasma concentration of varenicline
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measures including adverse events
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2010

Last Update Submitted That Met QC Criteria

January 7, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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