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NCT01311141 Clinical Trial

Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1

Healthy Clinical Trial

Official title:
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01311141
Other study ID # 2010-020778-41
Secondary ID
Status Completed
Phase Phase 4
First received March 8, 2011
Last updated March 31, 2011
Start date August 2010
Est. completion date March 2011

Study information
Verified date August 2010
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy

- Male

Exclusion Criteria:

- Female

- Ill

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• doripenem
doripenem once i.v.500mg

Locations
Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma
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