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A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

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

Summary

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.

Description

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

Conditions

Healthy

Intervention

Neratinib, Neratinib, Neratinib, Neratinib

Location

Pfizer Investigational Site
New Haven
Connecticut
United States
06511

Status

Recruiting

Source

Pfizer

Results (where available)

View Results

Links

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

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