NCT00731562

Brief Summary

  1. 1.To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
  2. 2.To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 11, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

August 7, 2008

Last Update Submit

January 7, 2010

Conditions

PharmacokineticsBioavailabilitySmoking Cessation

Keywords

food, varenicline, pharmacokinetics, bioavailability

Outcome Measures

Primary Outcomes (2)

  • 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).

    5 days

  • Maximum plasma concentration of varenicline

    1 day

Secondary Outcomes (1)

  • Safety measures including adverse events

    5 days

Study Arms (2)

Varenicline Controlled Release, Fasted

EXPERIMENTAL
Drug: Varenicline Tartrate Controlled Release

Varenicline Controlled Release, Fed

EXPERIMENTAL
Drug: Varenicline Tartrate Controlled Release

Interventions

Varenicline Tartrate Controlled ReleaseDRUG

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

Varenicline Controlled Release, Fasted

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female adult smokers
  • to 55 years of age

You may not qualify if:

  • Sensitivity to varenicline
  • Illegal drug use
  • Pregnant or nursing females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

East Grand Forks, Minnesota, 56721, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 11, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 11, 2010

Record last verified: 2010-01

Locations

US(2)