Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX

Exclusion Criteria

• •Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn products or any of the other ingredients of the Investigational Products
• •Subjects with impaired renal function based on the Cockcroft-Gault formula using actual body weight, i.e. estimated creatinine clearance \<= 80 mL/min (performed at Screening only)
• •Body Mass Index (BMI) \< 20.0 or \> 30.0 kg/m\^2
• •Body Weight \< 50.0 kg
• •White Blood Count (WBC) \< 3.5 x10\^3/uL or \> ULN
• •absolute neutrophil count (ANC) \< 1.5 x10\^3/uL or \> ULN
• •Alarine aminotransferase and aspartate aminotransferase \> upper limit of normal
• •Other laboratory tests that are outside the normal limits, considered by the investigator, to be clinically significant.
• •Use of any medication on a chronic basis.
• •Takes any medication which interferes with the study drug or study procedures including aminoglycosides, anticoagulants, and probenecids.
• •Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies from 14 days prior to Day -1 until end of study. By exception, acetaminophen \<= 1 gram per day is permitted.
• •Tobacco use during the last 2 months prior to enrollment.
• •Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
• •Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1
• •Positive blood test for ethanol at screening or Day -1.
• •At screening, the subject has a clinically relevant ECG change, as assessed by the PI or designee.
• •Concurrent acute or chronic infections (e.g. viral infections, except chronic recurrent herpes infections)
• •History of or ongoing alcohol abuse or drug abuse (within last 2 years).
• •Received an Investigational drug or device within 30 days of first dose of study drug
• •Clinically relevant medical conditions which are likely to interfere with the evaluation of the trial drug, e.g. COPD, metabolic disorders (such as clinical and sub-clinical diabetes mellitus), history of malignant diseases (within last 5 years), autoimmune diseases, and cardiovascular disease
• •Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
• •Any condition that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data
• •Unable or unwilling to adhere to the study-specified procedures and restrictions