Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults

Inclusion Criteria:

1. Male or female aged >/= 18 years;

2. Must weigh >/= 120 kg

3. Able to understand and sign the Informed Consent Form(s) (ICF);

4. Is scheduled for surgery that is expected to last less than 3 hours;

5. Is scheduled for any type of surgery where a single-dose perioperative cefazolinprophylaxis is appropriate.

Exclusion Criteria:

1. If female, is pregnant or lactating/breastfeeding.

2. If female that is of childbearing potential and sexually active, and is not using aneffective method of birth control, e.g., oral contraceptives, double barriermethods, hormonal injectable or implanted contraceptives, tubal ligation, or have apartner with a vasectomy.

3. Has a history of renal impairment -- Subject has an eGFR of <80 mL/min/1.73m2performed at Screening as calculated by the following equation: 186 x (Creatinine/88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black) (FDAGuidance for Industry Pharmacokinetics in Patients with Impaired Renal Function)

4. Has a known allergy or hypersensitivity to β lactam/cephalosporin antibiotics, cornproducts, or dextrose-containing products or solutions, or any of the otheringredients of Cefazolin for Injection United States Pharmacopeia (USP) and DextroseInjection USP in DUPLEX.

5. Has a result of any laboratory test (or repeat test, if done), obtained as standardof care, that is outside the normal limit of the site's laboratory reference rangeAND is considered by the investigator to be clinically significant.

6. Has had a recent (within 14 days prior to the planned surgery) administration ofcefazolin.

7. Has had administration of any medication (e.g., prescription, herbal,over-the-counter medication[s] or dietary supplements) known to interact withcefazolin within 5 days prior to the study treatment administration.

8. Has a known history of human immunodeficiency virus, hepatitis B, or hepatitis Cinfection.

9. Has a current history of medical condition(s), which in the opinion of theinvestigator, would interfere with the evaluation of the study treatment.

10. Has a known history of organ transplant.

11. Has a clinically relevant disease/dysfunction of or a history of severe cardiac,pulmonary or hepatic disease.

12. Is undergoing any cardiovascular procedure including, but not limited to, majorcardiac surgery, cardiac catheterizations (including electrophysiology studies),ablations, automatic implantable cardioverter-defibrillator (AICD), and pacemaker.

13. Has received any other investigational drug/device within 30 days prior to the studytreatment administration.

14. Has any planned medical intervention or personal event that might interfere withability to comply with the study requirements.

15. The subject has any condition that, in the opinion of the investigator, wouldcompromise the safety of the subject or the quality of the data.

16. Is unable or unwilling to adhere to the study-specified procedures and restrictions.

17. Is an employee of the Sponsor, Investigator or study-center, has direct involvementin the study or other studies under the direction of that Investigator orstudy-center, or is a family member of the employees or the Investigator.