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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 -
- •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
研究组 & 干预措施
Cefazolin 2g (Test)
干预措施: Cefazolin 2g for Injection USP and Dextrose Injection USP (Drug)
Cefazolin 1.5g (Control)
干预措施: Cefazolin 1.5g (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- To evaluate the safety of cefazolin 2g injection in total daily doses of 6g over 11 days of administration in healthy volunteers(Varies, over 11 days of infusion therapy)