OPEN LABEL PILOT OF SAFETY, PHARMACOKINETICS, & EFFICACY OF MIKASOME

安全性、药代动力学、

• 批准号: 6264241
• 负责人: BRUCE C MARSHALL
• 金额: $ 0.16万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264241
• 关键词: aminoglycoside antibiotics; clinical research; cystic fibrosis; drug screening /evaluation; human subject; human therapy evaluation; kanamycin; liposomes; pharmacokinetics; respiratory disorder chemotherapy

This category D study is designed to test the safety, pharmacokinetics, and efficacy of a liposomal amikacin preparation in stable patients with cystic fibrosis who are colonized with gram-negative bacteria. The GCRC Endoscopy Suite is used to perform serial bronchoalveolar lavage studies to determine concentration of the drug in the alveoli. The pharmacokinetic portion of the study also is well suited to the GCRC. Preliminary data on this study are not yet available for analysis.

这项D类研究旨在测试脂质体阿米卡星制剂在囊性纤维化患者中的安全性、药代动力学和疗效，这些患者都是革兰氏阴性菌定植的。GCRC内窥镜套件用于进行一系列的支气管肺泡灌洗研究，以确定药物在肺泡中的浓度。该研究的药代动力学部分也非常适用于GCRC。这项研究的初步数据尚不能用于分析。