A Single-Dose Pharmacokinetics Study of Tapimycin Injection

Tri-Service General Hospital

Status: Completed

Conditions: Healthy

Treatments: Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)

Study type: Interventional

Funder types: Other

Identifiers

NCT00924742

MCPEM08026M1

097-05-160

C163

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Test drug

Experimental group

Treatment:

Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)