Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1
1 other identifier
interventional
6
1 country
1
Brief Summary
In the present study we will measure and compare the unbound, i.e. microbiologically active concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis technique, which allows for the continuous measurement of unbound drug concentrations in the interstitial space fluid. The findings of the present study will help to assess whether currently employed therapy regimens with doripenem provide effective antimicrobial concentrations in different compartments in man
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Aug 2010
1 active site
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
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2011
CompletedApril 1, 2011
August 1, 2010
7 months
March 8, 2011
March 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma
Study Arms (1)
Doripenem i.v.
EXPERIMENTALno comparator, PK study
Interventions
Eligibility Criteria
You may qualify if:
- Healthy
- Male
You may not qualify if:
- Female
- Ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 8, 2011
First Posted
March 9, 2011
Study Start
August 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 1, 2011
Record last verified: 2010-08