An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
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.