Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1
NCT01311141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2011-04-01
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
Conditions
- Healthy
Interventions
- DRUG
-
doripenem
doripenem once i.v.500mg
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-08-31
- Primary Completion
- 2011-03-31
- Completion
- 2011-03-31
Countries
- Austria
Study Locations
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