Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX (2 Cef)
|Infection||Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP Drug: Cefazolin 1.5g||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g in a similar population of healthy adult subjects [ Time Frame: PK is evaluated on Days 1 and 11 of infusion therapy ]The primary objective is to evaluate the pharmacokinetics of an intravenous infusion of Cefazolin 2g for injection USP and Dextrose injection USP in healthy adult subjects at an infusion rate of 50 ml over 15 minutes, and Cefazolin 1.5g for injection USP and Dextrose injection USP in a similar population of healthy adult subjects.
- To evaluate the safety of cefazolin 2g injection in total daily doses of 6g over 11 days of administration in healthy volunteers [ Time Frame: Varies, over 11 days of infusion therapy ]
- Hematology(CBC): Hb, Hct, RBC count, RBC indices, RBC morphology, platelet count, WBC count, and differential WBC
- Clinical Chemistry: Sodium, potassium, chloride, Co2, glucose, ALT, AST, alkaline phosphatase, serum albumin, total bilirubin, blood urea nitrogen, and creatinine
- Urinalysis: specific gravity, protein, blood, nitrates, leukocyte esterase, glucose, ketone, appearance, pH
- Urine drug and blood alcohol tests
- C. difficile
- Vital signs: temperature, blood pressure, heart rate, and respiratory rate
- Adverse Events
- Physical exams
|Study Start Date:||December 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Experimental: Cefazolin 2g (Test)||
Drug: Cefazolin 2g for Injection USP and Dextrose Injection USP
Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
Other Name: Cefazolin 2g in DUPLEX (50ml)
|Active Comparator: Cefazolin 1.5g (Control)||
Drug: Cefazolin 1.5g
Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
Other Name: Cefazolin 1.5g (50ml)
B. Braun Medical Inc. intends to conduct human PK studies and obtain marketing approval for Cefazolin 2g in the United States with identical indications of those already approved for the 1g strength. A pharmacokinetic study will be conducted with the Cefazolin 2g product manufactured by B. Braun Medical Inc. Cefazolin 1.5g dose will be prepared using 10g Cefazolin pharmacy bulk with 5% Dextrose. The clinical study proposed in this protocol is designed to evaluate the pharmacokinetic characteristics of 2g and 1.5g Cefazolin in Dextrose in healthy subjects at the maximum recommended infusion dose of 6g per day per FDA's recommendation.
The study is designed to simulate clinical practice and overall experience with cephalosporin administration. Cefazolin may be reconstituted with dextrose (or a number of other diluents as recommended in the innovator's package insert) in order to achieve an osmolality appropriate for intravenous infusion.
According to B. Braun's approved package insert for Cefazolin 1g, the maximum dose of 1.5g Cefazolin for Injection USP and Dextrose Injection USP is 1.5 grams every 6 hours for severe, life-threatening infections. In rare instances, doses of up to 12 grams of Cefazolin per day have been used. Lower doses are stated in the B. Braun package insert.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121354
|United States, Maryland|
|PAREXEL Early Phase Clinical Unit|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Azra Hussaini, MD||Parexel|