kidney infection genital infection MedDRA version: 9.1 Level: LLT Classification code 10023424 Term: Kidney infection MedDRA version: 9.1 Level: LLT Classification code 10018152 Term: Genital infection bacterial NOS
Conditions
Interventions
Trade Name: COLIMYCINE
Product Name: COLIMYCINE
Product Code: J01XB01
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: COLISTIMETHATE SODIQUE
Concentration unit: mg/ml milligram(s)/mill
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects aged from 18 to 65, male - Without major known disease, - Non smokers or moderate smokers (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Outcome results
None listed