Status:
COMPLETED
A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Brief 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 st...
Detailed Description
The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01142063
Start Date
June 1 2010
End Date
September 1 2010
Last Update
May 14 2012
Active Locations (1)
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1
Investigational Site
New Haven, Connecticut, United States, 06511