Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01142063 · ClinicalTrials.gov registry record
A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
A clinical trial, sponsored by Puma Biotechnology.
- Completed
- Registry status
- 28
- Enrollment target
NCT01142063: Completed study, sponsored by Puma Biotechnology.
NCT01142063 is a clinical trial that has completed, run by Puma Biotechnology. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01142063 has completed, sponsored by Puma Biotechnology.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
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.
Interventions
- DRUG Neratinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-09 |
What the finished NCT01142063 record still lists
NCT01142063 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Neratinib is the first listed.
NCT01142063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01142063 about?
NCT01142063 is a clinical study titled "A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects". 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.
What is the current status of trial NCT01142063?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2010-06. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01142063?
The interventions under investigation include: Neratinib (DRUG).
Who is sponsoring clinical trial NCT01142063?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia