Overview

Pharmacokinetic Study of the Penetration of Ceftobiprole in the Bone

Status:
Completed

Trial end date:
2010-02-01

Target enrollment:
0

Participant gender:
All

Summary

This study is being performed to measure the amount of the antibiotic ceftobiprole (study drug) found in the bone and blood after receiving one dose prior to your elective hip replacement surgery. A piece of your hip bone which will be removed as part of your surgery will be analyzed to determine how much ceftobiprole gets into the bone.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Basilea Pharmaceutica

Treatments:

Ceftobiprole
Ceftobiprole medocaril
Cephalosporins

Criteria

Inclusion Criteria:

- Healthy men and women at least 18 years of age who have elected to undergo hip
replacement surgery. Subjects must be in overall good health with normal renal
function (a creatinine clearance of >50 mL/min).

Exclusion Criteria:

- Subjects must not have a history of repeated severe nausea with anesthesia, gastric or
duodenal ulcer, allergy to b lactam antibiotics, urinary obstruction or difficulty in
voiding.