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

NCT00731562 Phase 1 COMPLETED

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.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2008-07
Completion	2008-09

Conditions

• Pharmacokinetics
• Bioavailability
• Smoking Cessation

Interventions

• Varenicline Tartrate Controlled Release
• Varenicline Tartrate Controlled Release

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). — 5 days
• Maximum plasma concentration of varenicline — 1 day

Countries

United States