A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Neratinib In Healthy Subjects

The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.

The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.

Inclusion Criteria:

• An informed consent document signed and dated by the subject or a legally acceptable representative.
• Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 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 ECG, and clinical laboratory tests).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).