TEST EFFECT OF EFFECT OF NFV, RTV & SOFT GEL SQV

测试NFV、RTV效果

• 批准号: 6264325
• 负责人: TERRENCE F BLASCHKE
• 金额: $ 0.06万
• 依托单位: STANFORD UNIVERSITY
• 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/6264325
• 关键词: P glycoprotein; clinical research; dosage; drug screening /evaluation; high performance liquid chromatography; human subject; pharmacokinetics; protease inhibitor; virus protein

The purpose of this study is to determine whether the bioavailability of the three HIV protease inhibitors is affected by giving them together in contrast to separating the doses by several hours. The hypothesis being tested is that since at least two of these compounds are inhibitors of P-glycoprotein, co-administration of two protease inhibitors may increase the bioavailability of both by preventing their transport out of intestinal cells by P-glycoprotein. The design is a balanced Latin square, in an effort to minimize subjects and assays. Plasma samples are obtained after simultaneous and staggered dosing, and analyzed for drug concentration by HPLC. Standard non-compartmental pharmacokinetic analysis will be used to determine the effect, if any of the different times of administration. Enrollment in the protocol is now complete, samples have been collected, and laboratory assays and data analyses are ongoing. There are no preliminary results available at the present time.

本研究的目的是确定三种HIV蛋白酶抑制剂的生物利用度是否会受到一起给药的影响，而不是分开几个小时给药。正在检验的假设是，由于这些化合物中至少有两种是P-糖蛋白的抑制剂，因此两种蛋白酶抑制剂的联合给药可能会通过阻止它们被P-糖蛋白转运出肠细胞而增加两者的生物利用度。设计是一个平衡的拉丁方，以尽量减少受试者和测定。在同时和交错给药后获得血浆样品，并通过HPLC分析药物浓度。将使用标准非房室药代动力学分析确定效应（如果不同给药时间）。方案中的入组现已完成，样本已采集，实验室检测和数据分析正在进行中。目前尚无初步结果。