NCT00731562

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-08-11
• Last updated: 2010-01-11

Locations

2 sites across 1 country: United States