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

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.

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