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

NCT00731562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-01-11

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Bioavailability
  • Smoking Cessation

Interventions

DRUG

Varenicline Tartrate Controlled Release

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

DRUG

Varenicline Tartrate Controlled Release

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00731562 on ClinicalTrials.gov