NCT01142063

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-06-11
• Last updated: 2012-05-14

Locations

1 site across 1 country: United States