NEORAL (TM) IN STABLE RENAL TRANSPLANT PATIENTS

NEORAL (TM) 在稳定肾移植患者中的应用

• 批准号: 6244615
• 负责人: ALAN B LEICHTMAN
• 金额: $ 2.22万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-20 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244615
• 关键词: clinical research; cyclosporines; drug screening /evaluation; human subject; human therapy evaluation; kidney transplantation; oral administration; pharmacokinetics; transplant rejection

Greater predictability in the oral dosing of cyclosporin A (CSA) may minimize the number and duration of subtherapeutic or toxic events in organ transplantation, thus improving allograft survival. We have recently established that the bioavailability of the standard formulation of CSA (Sandimmune) in stable renal transplant recipients under steady state conditions is largely determined by both enteric and hepatic P4503A4 activity. Recently, a newly developed microemulsion formulation of CSA (Neoral) has demonstrated improved and more predictable bioavailability compared to Sandimmune. As a result, the improved correlation between trough CSA levels and AUC may facilitate the management of transplant patients, particularly those with CSA absorption difficulties. The improved pharmacokinetics associated with Neoral may be largely due to the ability of the microemulsified CSA to bypass enteric metabolism.

口服环孢素A （CSA）剂量的可预测性更强