A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

2014-08-27 03:13:01 | BioPortfolio


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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective




Neratinib, Neratinib, Neratinib, Neratinib


Pfizer Investigational Site
New Haven
United States





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:01-0400

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