INTRAVENOUS BOLUS/INFUSION SAFETY AND PHARMACOKINETIC STUDY OF ABLC

ABLC 静脉推注/输注安全性和药代动力学研究

• 批准号: 3896287
• 负责人: J BENNETT
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3896287
• 关键词: amphotericin B; antifungal agents; antifungal antibiotics; diagnosis procedure safety; drug administration routes; drug adverse effect; drug metabolism; high performance liquid chromatography; intravenous administration

The purpose of this study is to assess the safety and pharmacokinetics of Amphotericin B lipid complex when administered to healthy male volunteers as a single 1 mg intravenous bolus test dose followed sequentially by infusions of 0.1 mg/kg, 0.25 mg/kg body weigh compared to the same dosage regimens of Fungizone (registered trademark). Sixteen subjects are to be enrolled. Serum concentrations will be measured by a highly specific, sensitive and reproducible HPLC method. The sensitivity of the method is 25 ng/ml. The standard curves are linear from 25 ng/ml to 20 ug/ml. This method was developed in the CPRL.

本研究的目的是评估的安全性和药物动力学