Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver
After given informed consent, patients scheduled for planned liver resection are enrolled
into the study. The patients receive MXF 400 mg as one hour intravenous infusion at
randomized timed intervals prior to liver resection. Blood and healthy liver tissue are
sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a
subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36
and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying
a two-compartment model.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Concentration (mg/L) of moxifloxacin in liver tissue
The first outcome of this study was to analyze the concentration of MFX in liver tissue of patients who received MFX 400 mg i.v..
1.5 hours after moxifloxacin infusion
No
Martin K Schilling, MD
Principal Investigator
University hospital of the Saarland
Germany: Federal Institute for Drugs and Medical Devices
24/06
NCT01302951
July 2008
July 2010
Name | Location |
---|