NCT01302951

Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.

Study on Pharmacokinetics of Moxifloxacin in Serum and Liver Tissue of Patients Undergoing Liver Resection Due to Primary or Secondary Tumor of the Liver

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

Detailed description

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.

Conditions

• Side-effect of Antibiotic

Interventions

Type	Name	Description
DRUG	Moxifloxacin 400 mg	The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2011-02-24
• Last updated: 2011-02-24

Locations

1 site across 1 country: Germany