EUCTR2007-003092-39-FR进行中（未招募）不适用
Pharmacokinetics of colistimethate and colistine after a 60 minutes intravenous infusion of colistimethate 1 million UI (80 mg) in 12 healthy volunteers
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •-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.
研究者
相似试验
进行中（未招募）
1 期
Pharmacokinetic/pharmacodynamic aspects of colistin intravenous administration in critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.Critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.MedDRA version: 20.0Level: PTClassification code 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-001019-95-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE20
进行中（未招募）
不适用
Pharmacokinetic and colimicine (ColistinaR) concentrations in broncho alveolar lavage in patients affected by pulmonary infections caused by Gram - bacteria. - NDEUCTR2007-005045-38-ITOSPEDALE POLICLINICO S. MATTEO
尚未招募
Unknown
Clinical efficacy and pharmacokinetics of colistimethate sodium in pediatric patients.CTRI/2023/04/051382AIIMS RAIPUR
已完成
4 期
A clinical trial to determine pharmacokinetics of Colistin given as injection, in subjects with hospital acquired infections caused by gram negative bacilli.CTRI/2009/091/000252Cipla Ltd12
Unknown
4 期
Colistin Pharmacokinetics in Continuous Renal Replacement TherapyInfectionNCT02081560University of Zurich10