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

NCT ID: NCT01311141

Last Updated: 2011-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-03-31

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Doripenem i.v.

no comparator, PK study

Group Type: EXPERIMENTAL

doripenem

Intervention Type: DRUG

doripenem once i.v.500mg

Interventions

doripenem

doripenem once i.v.500mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy
• Male

Exclusion Criteria

• Female
• Ill

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

2010-020778-41

Identifier Type: -

Identifier Source: org_study_id