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A Single-Dose Pharmacokinetics Study of Tapimycin Injection

This study has been completed.
Sponsor:
Information provided by:
Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT00924742
First received: June 18, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • To examine the pharmacokinetic properties [ Time Frame: 8.5 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924742

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

No publications provided

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, 097-05-160, C163
Study First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Piperacillin
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013