NCT01121354 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

APP Pharmaceuticals, LLC
Package Insert, Cefazolin for Injection, USP. 451180, July 2008, Schaumburg, IL 60173 (USA).
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. Epub 2007 Jan 12.

A Phase I Multiple-Dose Two-Arm Study to Evaluate the PK and Safety of Cefazolin 2g for Inj. USP and Dextrose Inj. USP in the DUPLEX® Drug Delivery System and Cefazolin for Inj. 1.5g in Daily Doses of 6g in Healthy Adult Subjects

Details for clinical trial NCT01121354

Clinical trial NCT01121354 - References