NCT01678690

An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: InnoPharmax Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Tumors

Interventions

Type	Name	Description
DRUG	Gemcitabine HCl Oral Formulation	Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-09-05
• Last updated: 2016-09-02

Locations

4 sites across 2 countries: United States, Taiwan