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

Pfizer24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetics Bioavailability Smoking Cessation

Interventions

Varenicline Tartrate Controlled ReleaseDRUG

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

Varenicline Tartrate Controlled ReleaseDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

East Grand Forks, Minnesota, United States

Pfizer Investigational Site

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

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

Maximum plasma concentration of varenicline

Time frame: 1 day

Secondary Outcomes

Safety measures including adverse events

Time frame: 5 days

Data from ClinicalTrials.gov

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