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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: doripenem

Study type: Interventional

Funder types: Other

Identifiers

NCT01311141

2010-020778-41

Details and patient eligibility

About

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

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Male

Exclusion criteria

• Female
• Ill

Trial design

6 participants in 1 patient group

Doripenem i.v.

Experimental group

Description:

no comparator, PK study

Treatment:

Drug: doripenem