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: 6112864
• 负责人: JOHN C CURTIS
• 金额: $ 2.95万
• 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: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112864
• 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 initial 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.

自1983年美国FDA批准以来，Sandimmune在预防同种异体移植后器官排斥方面积累了丰富的临床经验。这种药物的不良事件的概况是很好的发展，然而，生物等效性的初步评估是在正常受试者中进行的。环孢素的口服生物利用度在移植患者中表现出不同，主要是由于药物吸收特性的不同。此外，个别报告强调，当肾移植受者从口服溶液转换为胶囊时，两种口服环孢素制剂之间存在一些药代动力学差异。因此，本研究在环孢素吸收不良的肾移植患者中，比较了沙得孟口服液与沙得孟软明胶胶囊的生物等效性。