Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01678690
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2012-08-29
Brief Title:
An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation D07001-F4 in Subjects With Malignant Tumors
Sponsor:
InnoPharmax Inc
Organization:
InnoPharmax Inc
Study Overview
Official Title:
An Open-Label Exploratory Limited Dose Escalation Study to Evaluate the Pharmacokinetics Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation D07001-F4 in Subjects With Malignant Tumors
Status:
COMPLETED
Status Verified Date:
2016-08
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:
Open-label Phase 0 dose-escalation study of 3 successive cohorts 3 subjects per cohort to determine and characterize the plasma PK of gemcitabine HCl oral formulation D07001-F4 administered once on Day 1 with 7 Days of study follow-up In addition oral tolerability and safety will also be assessed during this 1-week period
Detailed Description:
None
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