Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-05 @ 7:34 PM
Study NCT ID:
NCT02097433
Status:
COMPLETED
Last Update Posted:
2014-10-03
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1 Open-label Study To Characterize The Pharmacokinetics Of A Single 45 Mg Oral Dose Of Dacomitinib (Pf-00299804) In Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2014-10
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:
As part of the global clinical development program for Dacomitinib, studies are planned in cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.
The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.
The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.
Detailed Description:
To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.
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?: