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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: AG-013736

Study type: Interventional

Funder types: Industry

Identifiers

NCT01020136

A4061063

Details and patient eligibility

About

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.

Full description

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

Enrollment: 42 patients

Sex: All

Ages: 21 to 47 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

Sequence 1 (BABA)

Experimental group

Description:

Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -\> A -\> B -\> A

Treatment:

Drug: AG-013736

Drug: AG-013736

Sequence 2 (ABAB)

Experimental group

Description:

Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -\> B-\> A -\> B

Treatment:

Drug: AG-013736

Drug: AG-013736