Pharmacokinetics of colistimethate and colistine after a 60 minutes intravenous infusion of colistimethate 1 million UI (80 mg) in 12 healthy volunteers

• Conditions: kidney infectiongenital infection; MedDRA version: 9.1Level: LLTClassification code 10023424Term: Kidney infection; MedDRA version: 9.1Level: LLTClassification code 10018152Term: Genital infection bacterial NOS

• Registration Number: EUCTR2007-003092-39-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Subjects aged from 18 to 65, male
-Without major known disease,
-Non smokers or moderate smokers (< 15 cigarettes p. day),
-During the study, subjects accepted to drink 250 ml p. hour during the 4th first hours, then 100 ml p. hour next hours,
-Subjects accepted to feed only with the collations which are proposed to them,
-Non pathologic blood pressure and heart rate,
-A written assent must be 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Hypersensitivity to colistine or polymyxines,
-Familial or personal known myasthenia,
-Renal, hepatic, cardiac, hematologic, neurologic, psychiatric or digestive known disease
-Asthma or severe allergy ,
-Surgical operation during the previous month,
-Drug or alcohol addiction,
-Previous administration of colistine or other medication. Other planned administration of any medication during the study.
-Blood gift during the previous month
-Positive HIV, HBV et HCV serological status.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Plasmatic and urinary concentrations, pharmacokinetics parameters of colistine and colistimethate. ;Secondary Objective: Evaluation of safety. ;Primary end point(s): Plasmatic and urinary concentrations, pharmacokinetics parameters of colistine and colistimethate.