OPEN PHASE I STUDY OF PHARMACOKINETICS AND TOLERABILITY OF RP59500

RP59500 药代动力学和耐受性的 I 期开放研究

• 批准号: 6276467
• 负责人: JOHN E CONTE
• 金额: $ 6.43万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6276467
• 关键词: antibiotics; blood chemistry; chronic renal failure; clinical research; clinical trial phase I; cyclic peptides; dosage; drug screening /evaluation; human subject; human therapy evaluation; injection /infusion; kidney disorder chemotherapy; pharmacokinetics; plasma; volunteer

The purpose of this study is a) to determine the pharmacokinetics of RP59500 synercid and compare the pharmacokinetic profile after single and multiple doses in volunteers with moderate or severe chronic renal failure, and b) to assess the clinical and biological tolerability of multiple doses of RP59500 Synercid in these same subjects. The subjects will be admitted to the GCRC and receive multiple infusions of the drug. Serial blood specimens will be obtained and analyzed for drug concentration by the investigator.

本研究的目的是a）确定以下药物的药代动力学： RP59500协同作用，并比较单次给药和 在中度或重度慢性肾脏病志愿者中多次给药 失败，和B）评估的临床和生物耐受性 在这些相同的受试者中进行RP 59500 Synercid的多次给药。 受试者 将进入GCRC并接受多次药物输注。 将获得一系列血液样本并进行药物分析 研究者的浓度。