A Single-Dose Pharmacokinetics Study of Tapimycin Injection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 25. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test drug<br> | Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)<br>* One intravenous infusion (piperacillin 4 g + tazobactam 0.5 g powder for injection) over 30 minutes/single dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the pharmacokinetic properties |  | 8.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The PK of Tapimycin, volunteer