An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
NCT00731562
Last updated date
ABOUT THIS STUDY
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 Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Pharmacokinetics, Bioavailability, Smoking Cessation
Sex
Females and Males
Age
18-55 years
Inclusion Criteria
Show details
- Healthy male or female adult smokers
- 18 to 55 years of age
Exclusion Criteria
Show details
- Sensitivity to varenicline
- Illegal drug use
- Pregnant or nursing females
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Pharmacokinetics, Bioavailability, Smoking CessationAn Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
NCT00731562
- East Grand Forks, Minnesota
- Fargo, North Dakota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation | |||
Official Title ICMJE | 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 | |||
Brief Summary |
| |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 24 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2008 | |||
Actual Primary Completion Date | September 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00731562 | |||
Other Study ID Numbers ICMJE | A3051088 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |