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A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

NCT01142063 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2012-05-14

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Neratinib

Tablet, a 240 mg single oral dose

DRUG

Neratinib

Tablet, a 240 mg single oral dose

DRUG

Neratinib

Tablet, a 240 mg single oral dose

DRUG

Neratinib

Tablet, a 240 mg single oral dose

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Puma · Biotechnology

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01142063 on ClinicalTrials.gov