Status:
COMPLETED
A Single-Dose Pharmacokinetics Study of Tapimycin Injection
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00924742
Start Date
March 1 2009
End Date
May 1 2009
Last Update
June 19 2009
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