Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT00814060
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)
Sponsor:
Puma Biotechnology, Inc.
Organization:
Study Overview
Official Title:
A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: