A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
NCT ID: NCT01142063
Last Updated: 2012-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
28 participants
OBSERVATIONAL
2010-06-30
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
NCT00864968
A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers
NCT03860948
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
NCT03536481
A Study to Evaluate the the Bioequivalence of Two Different Pimicotinib Capsules in Healthy Subjects
NCT07126249
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
NCT06418607
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A (Reference fasted)
Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition.
Neratinib
Tablet, a 240 mg single oral dose
Treatment B (Test fasted)
Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition.
Neratinib
Tablet, a 240 mg single oral dose
Treatment C (Reference fed)
Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition.
Neratinib
Tablet, a 240 mg single oral dose
Treatment D (Test fed)
Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition.
Neratinib
Tablet, a 240 mg single oral dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neratinib
Tablet, a 240 mg single oral dose
Neratinib
Tablet, a 240 mg single oral dose
Neratinib
Tablet, a 240 mg single oral dose
Neratinib
Tablet, a 240 mg single oral dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* Any condition possibly affecting drug absorption (eg, gastrectomy).
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Puma Biotechnology, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Puma
Role: STUDY_DIRECTOR
Biotechnology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational Site
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3144A1-1127
Identifier Type: -
Identifier Source: secondary_id
B1891021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.