A Single-Dose Pharmacokinetics Study of Tapimycin Injection

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)

• Registration Number: NCT00924742
• Lead Sponsor: Tri-Service General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Last Update Submitted: 2009-06-18
• Study First Posted: 2009-06-19
• Last Update Posted: 2009-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1. 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.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index (BMI) between 18.5 and 25.
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry.
6. No significant deviation from normal hematology.
7. No significant deviation from normal urinalysis.

Exclusion Criteria

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Acute or chronic diseases or having undergone surgery from 4 weeks prior to PeriodI dosing.
4. Any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical study drug from 3 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody.
11. A positive test for HIV antibody.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test drug	Tapimycin (piperacillin 4 g + tazobactam 0.5g)	-

Primary Outcome Measures

Name	Time	Method
To examine the pharmacokinetic properties	8.5 hours