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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731562

Enrollment

Registered

2008-08-11

Start date

2008-07-31

Completion date

2008-09-30

Last updated

2010-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioavailability, Pharmacokinetics, Smoking Cessation

Keywords

food, varenicline, pharmacokinetics, bioavailability

Brief summary

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.

Interventions

DRUGVarenicline Tartrate Controlled Release

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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).	5 days
Maximum plasma concentration of varenicline	1 day

Secondary

Measure	Time frame
Safety measures including adverse events	5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026