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A Single-Dose Pharmacokinetics Study of Tapimycin Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00924742
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : June 19, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Healthy Drug: Tapimycin (piperacillin 4 g + tazobactam 0.5g)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : March 2009
Primary Completion Date : April 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. To examine the pharmacokinetic properties [ Time Frame: 8.5 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924742

Sponsors and Collaborators
Tri-Service General Hospital
Principal Investigator: Feng-Yee Chang Tri-Service General Hospital

Responsible Party: Feng-Yee Chang/The Head of Department of Internal Medicine, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT00924742     History of Changes
Other Study ID Numbers: MCPEM08026M1
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009

Keywords provided by Tri-Service General Hospital:
The PK of Tapimycin

Additional relevant MeSH terms:
Penicillanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action