A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

Completed

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01142063

Run by

Puma Biotechnology, Inc.

People needed

28

Starts

2010-06-01

Expected to finish

2010-09-01

Last updated by the study team

2012-05-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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