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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Bioavailability; Smoking Cessation; Pharmacokinetics

Treatments: Drug: Varenicline Tartrate Controlled Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731562

A3051088

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Varenicline Controlled Release, Fasted

Experimental group

Treatment:

Drug: Varenicline Tartrate Controlled Release

Drug: Varenicline Tartrate Controlled Release

Varenicline Controlled Release, Fed

Experimental group

Treatment:

Drug: Varenicline Tartrate Controlled Release

Drug: Varenicline Tartrate Controlled Release