Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: B. Braun Medical Inc.
• Collaborator: Parexel
• Treatments: Cefazolin

Criteria

Inclusion Criteria:

• Healthy subjects, male and female

• Age: 18 - 70 years (inclusive) at the time of screening.

• Females of non-child bearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal >= 1 year with follicle stimulating hormone [FSH] > 40 U/L).

• Healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory evaluations).

• Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent and the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to performing any of the screening procedures.

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