A Single-Dose Pharmacokinetics Study of Tapimycin Injection
3 other identifiers
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Mar 2009
Shorter than P25 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 18, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedJune 19, 2009
June 1, 2009
1 month
June 18, 2009
June 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To examine the pharmacokinetic properties
8.5 hours
Study Arms (1)
Test drug
EXPERIMENTALInterventions
One intravenous infusion (piperacillin 4 g + tazobactam 0.5 g powder for injection) over 30 minutes/single dosing
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feng-Yee Chang
Tri-Service General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 18, 2009
First Posted
June 19, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
June 19, 2009
Record last verified: 2009-06