ORAL SOLUTIONS OF SANG35 VERSUS NEORAL IN STABLE ADULT RENAL ALLOGRAFTS

SANG35 与 NEORAL 在稳定成人肾同种异体移植物中的口服溶液

• 批准号: 6303051
• 负责人: Robert S Gaston
• 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: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303051
• 关键词: clinical research; cyclosporines; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; immunosuppressive; kidney disorder chemotherapy; kidney transplantation; oral administration; pharmacokinetics; transplant rejection

This study examined the effect of converting stable renal transplant recipients from Neoral. brand of cyclosporine to SangCyA., a new bioequivalent preparation. The study was blinded, with a crossover design. Half of 45 subjects were randomized to receive SangCya for 2 weeks, then switched back to Neoral for the remainder of one year. The other half remained on Neoral for 2 weeks, then swithched to SangCya for the duration. Pharmacokinetic profiles were obtained prior to each change in cyclosporine preparation, and again at six months. The results of the study documented that patients on both preparations fared equally well clinically, and no difference was observed in trough cyclosporine blood levels or pharmacokinetic profiles between the two study groups. This study is now complete; a final IRB report has not yet been submitted.

本研究检验了稳定肾移植受者从 Neoral 转变的效果。环孢素品牌为SangCyA.，一种新的生物等效制剂。 该研究采用盲法，采用交叉设计。 45 名受试者中的一半被随机接受 SangCya 治疗 2 周，然后转回 Neoral 治疗一年。 另一半则继续服用 Neoral 两周，然后在此期间改用 SangCya。 在环孢素制剂每次改变之前以及六个月后再次获得药代动力学特征。 研究结果证明，服用两种制剂的患者临床表现同样良好，并且两个研究组之间的环孢素血药浓度或药代动力学特征没有观察到差异。 这项研究现已完成；最终IRB报告尚未提交。