A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

A Phase 1 Bioequivalence Study To Compare The Plasma Pharmacokinetics Of AG-013736 Polymorph Form IV Versus Market-Image Polymorph Form XLI Tablets In Healthy Volunteers Under Fed Conditions

The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.

To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 47 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and clinical laboratory tests)
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
• An informed consent document signed and dated by the subject or a legally acceptable representative

Exclusion Criteria:

• Evidence of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies)
• Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
• Pregnant or nursing females and females of childbearing potential including those with tubal ligation