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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00731562
First received: August 7, 2008
Last updated: January 7, 2010
Last verified: January 2010
  Purpose
  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 Intervention Phase
Pharmacokinetics
Bioavailability
Smoking Cessation
Drug: Varenicline Tartrate Controlled Release
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of varenicline [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety measures including adverse events [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00731562     History of Changes
Other Study ID Numbers: A3051088
Study First Received: August 7, 2008
Last Updated: January 7, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014