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Completed

NCT Number: NCT00924742

A Single-Dose Pharmacokinetics Study of Tapimycin Injection

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Tapimycin (piperacillin 4 g + tazobactam 0.5g)

Drug

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

Primary outcomes

  1. To examine the pharmacokinetic properties

    Time frame: 8.5 hours

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2009
Registry last updated
Jun 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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