BIOAVAILABLITY IN FASTING OF SANDIMMUNE ORAL SOLUTION VS SOFT GELATIN CAPSULES

SANDIMUNE 口服溶液与软明胶胶囊空腹时的生物利用度

• 批准号: 6274098
• 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/6274098
• 关键词: clinical research; cyclosporines; dosage forms; drug adverse effect; gastrointestinal absorption /transport; human subject; human therapy evaluation; kidney transplantation; oral administration; pharmacokinetics; transplant rejection

Extensive clinical experience with Sandimmune in prophylaxis of organ rejection following allogenic transplantation has amassed since United States FDA approval in 1983. The profile of adverse events with this drug is well developed, however, the inital evaluation of the bioequivalence was performed in normal subjects. The oral bioavailability of cyclosporine was shown to be different in transplant patients, mainly due to drug absorption characteristics. Also isolated reports have underlined some pharmacokinetic difference between the two oral formulations of cyclosporine when renal transplant recipients were converted from the oral solution to capsules. Therefore, this study evaluates the bioequivalence of Sandimmune oral solution compared to Sandimmune soft gelatin capsules in renal transplant patients with poor absorption of cyclosporine.

Sandimmune 预防器官损伤的丰富临床经验 自联合以来同种异体移植后的排斥反应已经积累 1983 年获得 FDA 批准。该药物的不良事件概况 然而，生物等效性的初步评价已经很成熟 在正常受试者中进行。环孢素的口服生物利用度 移植患者的表现有所不同，主要是由于药物的影响 吸收特性。 个别报告也强调了一些 两种口服制剂的药代动力学差异 当肾移植受者从口服转为环孢素时 溶液成胶囊。因此，本研究评估生物等效性 Sandimmune口服液与Sandimmune软明胶胶囊的比较 环孢素吸收不良的肾移植患者。