A Single-Dose Pharmacokinetics Study of Tapimycin Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To examine the pharmacokinetic properties	8.5 hours

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Feng-Yee Chang, Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Estimate): June 19, 2009
• Last Update Submitted That Met QC Criteria: June 18, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: volunteer; The PK of Tapimycin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Piperacillin; Tazobactam
• Other Study ID Numbers: MCPEM08026M1; 097-05-160; C163