drugset / Trial / NCT01121354
Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin 1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult subjects for 11 days of administration.
Timeline
- Start
- 2009-12
- Primary completion
- 2010-02
- Completion
- 2010-02
Publications
- Background Abraxis Pharmaceutical Products, Package Insert, Cefazolin for Injection, USP.45858E, July 2006, Schaumburg, IL 60173 (USA).
- Background Apotex Corp., Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. 948025398, December 2005, Weston, FL 33326 (USA).
- Background APP Pharmaceuticals, LLC. Package Insert, Cefazolin for Injection, USP. 451180, July 2008, Schaumburg, IL 60173 (USA).
- Background Hospira, Inc. Package Insert, Cefazolin for Injection, USP, Pharmacy Bulk Pack. EN-1961/948025777, December 2008, Lake Forest, IL 60045 (USA).
- Background B. Braun Medical inc., Package Insert, Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX Container, 1g, Apr 2008, Allentown, PA 18109 (USA).
- Background Vella-Brincat JW, Begg EJ, Kirkpatrick CM, Zhang M, Chambers ST, Gallagher K. Protein binding of cefazolin is saturable in vivo both between and within patients. Br J Clin Pharmacol. 2007 Jun;63(6):753-7. doi: 10.1111/j.1365-2125.2006.02827.x. Epub 2007 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cefazolin | Small molecule | 1.5 g | Intravenous |
| Subject | Cefazolin | Small molecule | 2 g | Intravenous |