STABLE RENAL TRANSPLANT PATIENTS CONVERTED FROM SANDIMMUNE TO NEORAL

稳定的肾移植患者从 SANDIMUNE 转为 NEORAL

• 批准号: 6274048
• 负责人: JOHN C CURTIS
• 金额: $ 2.59万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-01-26 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274048
• 关键词: artificial immunosuppression; clinical research; cyclosporines; dosage; dosage forms; gastrointestinal absorption /transport; heart transplantation; human subject; human therapy evaluation; kidney transplantation; liver transplantation; pharmacokinetics

Cyclosporine A is an established form of immunosuppressive treatment in organ transplantation involving kidney, liver, or heart. The absorption of cyclosporine during chronic administration of Sandimmune soft gelatin capsules and oral solution is known to be highly variable. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporin A blood levels and subsequent dose adjustments be made in order to avoid either toxicity due to high levels or posible organ rejection due to low levels of cyclosporine A. Neoral is a new form of Sandimmune which utilizes a microemulsion technique that facilitates the absorption of cyclosporin A. In healthy normal volunteers, administration of Neoral soft gelatin capsules has demonstrated consistent and improved absorption characteristics resulting in a more predictable pharmacokinetic profile relative to Sandimmune soft gelatin capsules. It is hypothesized that this new microemulsion formulation of Sandimmune, because of its more consistent and improved absorption characteristics, will facilitate the management of transplant patients.

环孢菌素A是一种公认的免疫抑制疗法 器官移植涉及肾、肝或心脏的器官移植吸收 环孢素在桑地蒙软凝胶慢性给药中的应用 胶囊和口服液是已知的高度可变的。它是 建议患者服用软明胶胶囊或口服 对一段时间内的溶液进行重复间隔监测 环孢素A血药浓度和随后的剂量调整 以避免因高水平或可能的器官引起的毒性 低水平环孢素A引起的排斥反应。 尼奥拉是一种新的三聚氰胺，它利用微乳 促进环孢素A在健康人体内吸收的技术 正常志愿者服用纽奥拉软胶囊后有 表现出一致的和改进的吸收特性，从而 在与Sandimmune Soft相比更可预测的药代动力学曲线中 明胶胶囊。据推测，这种新型微乳 三地蒙的配方，因为它更一致和改进 吸收特性，将便于移植管理 病人。