Determining the tissue concentration of the antibiotic, dicloxacillin, using the Microdialysis technique (on healthy male subjects)

Phase 1

• Conditions: The trial is conducted on healthy male volunteers. An intravenous dose of 2 grams of dicloxacillin is administered intravenously and the muscle- and subcutaneous tissue concentrations are measured using Microdialysis. Plasma concentrations are also measured and the tissue concentration is compared to the plasma concentration to evaluate the tissue distribution of dicloxacillin. A small amount of dicloxacillin (0,25 g) is administered via the Microdialysis catheter as part of the investigation.; MedDRA version: 17.0Level: LLTClassification code 10059428Term: Postoperative infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-000826-39-DK
• Lead Sponsor: Ortopædkirurgisk afdeling Odense Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

-Healthy male with no comorbidity
-No allergies or intolerance to dicloxacillin or lidocaine
-Age between 18 and 30 years
-Ability to, and willingness to follow instructions during the trial
-Informed, written consent, has been read, understood and signed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Persons who do not speak or understand Danish
-Persons with known acute or chronic illness
-Persons who are currently using medication
-Persons who are severely adipose
-Persons who are current smokers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified