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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 is a clinical trial that has completed, run by Puma Biotechnology. The registered enrollment target is 28 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01142063
The ClinicalTrials.gov registry entry for NCT01142063 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neratinib is the first listed.
NCT01142063 reports 0 study locations.
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.
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