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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00924742

Enrollment

Registered

2009-06-19

Start date

2009-03-31

Completion date

2009-05-31

Last updated

2009-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

The PK of Tapimycin, volunteer

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.

Interventions

DRUGTapimycin (piperacillin 4 g + tazobactam 0.5g)

One intravenous infusion (piperacillin 4 g + tazobactam 0.5 g powder for injection) over 30 minutes/single dosing

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To examine the pharmacokinetic properties	8.5 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026