A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AG-103736; Drug: AG-013736

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905814

A4061052

Details and patient eligibility

About

The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.

Enrollment: 60 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).
• Active smokers or users of tobacco containing products and other drugs
• Pregnant or nursing females; females of childbearing potential including those with tubal ligation.

Trial design

60 participants in 2 patient groups

Sequence 1 (BABA)

Other group

Description:

Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: B -\> A -\> B -\> A

Treatment:

Drug: AG-013736

Sequence 2 (ABAB)

Other group

Description:

Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: A -\> B -\> A -\> B

Treatment:

Drug: AG-103736