Overview

Pediatric Cefazolin PK Study

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. The secondary objectives of this study are: - To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin. - To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.
Phase:
Phase 1
Details
Lead Sponsor:
B. Braun Medical Inc.
Treatments:
Cefazolin