Ignite Creation Date:
2024-05-05 @ 10:38 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01154218
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2010-06-29
Brief Title:
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 1 Single Dose Bioequivalence And Food Effect Study In Healthy Volunteers Comparing The Commercial Image Capsules To The Immediate Release Tablets And Powder In Capsule Formulations Of Crizotinib PF-02341066 And The Commercial Image Capsule In The Fasted To Fed State
Status:
COMPLETED
Status Verified Date:
2011-10
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:
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule CIC relative to the Immediate Release Tablet IRT of crizotinib bioequivalence of CIC relative to Powder in Capsule PIC of crizotinib and lack of an effect of high fat meal on the pharmacokinetics PK of crizotinib when administered as CIC Formulation in healthy volunteers
Detailed Description:
The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC relative to PIC and lack of an effect of food on the PK of crizotinib in healthy volunteers
Study Oversight
Has Oversight DMC:
None
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?:
None