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

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ClinicalTrials.gov Identifier: NCT01311141
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : April 1, 2011
Sponsor:
Information provided by:
Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Healthy Drug: doripenem Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study
Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Doripenem

Arm Intervention/treatment
Experimental: Doripenem i.v.
no comparator, PK study
Drug: doripenem
doripenem once i.v.500mg




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Male

Exclusion Criteria:

  • Female
  • Ill

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311141


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

ClinicalTrials.gov Identifier: NCT01311141     History of Changes
Other Study ID Numbers: 2010-020778-41
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: August 2010