NCT00924742已完成不适用
A Single-Dose Pharmacokinetics Study of Tapimycin Injection(Piperacillin 4 g + Tazobactam 0.5 g Powder for Injection) Administered Under Fasting Conditions to Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- To examine the pharmacokinetic properties
研究概览
简要总结
The purpose of this study is to examine the pharmacokinetic properties of Tapimycin injection (piperacillin 4 g + tazobactam 0.5 g powder for injection) in healthy volunteers under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- •Healthy adult male, aged between 20 and 40 years old.
- •Body Mass Index (BMI) between 18.5 and
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- •No significant deviation from normal biochemistry.
- •No significant deviation from normal hematology.
- •No significant deviation from normal urinalysis.
排除标准
- •History of drug or alcohol abuse within the past year.
- •Medical history of severe drug allergy or sensitivity to analogous drug.
- •Acute or chronic diseases or having undergone surgery from 4 weeks prior to PeriodI dosing.
- •Any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- •Ongoing peptic ulcer and constipation.
- •Planned vaccination during the time course of the study.
- •Taking any clinical study drug from 3 months prior to Period I dosing.
- •Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
- •Blood donation of more than 500 mL within the past 3 months.
- •A positive Hepatitis B surface antigen or positive Hepatitis C antibody.
- •A positive test for HIV antibody.
研究组 & 干预措施
Test drug
Experimental
干预措施: Tapimycin (piperacillin 4 g + tazobactam 0.5g) (Drug)
结局指标
主要结局
To examine the pharmacokinetic properties
时间窗: 8.5 hours
次要结局
未报告次要终点
研究者
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