TWO DOSES STUDY TO COMPARE THE SAFETY OF SDZ RAD IN HEART/LUNG TRANSPLANT

比较 SDZ RAD 在心/肺移植中的安全性的两种剂量研究

• 批准号: 6305171
• 负责人: RANDALL E MORRIS
• 金额: $ 0.06万
• 依托单位: STANFORD UNIVERSITY
• 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/6305171
• 关键词: body weight; clinical research; clinical trials; cystic fibrosis; dosage; drug administration rate /duration; drug metabolism; drug screening /evaluation; endocrine disorder chemotherapy; heart transplantation; human subject; human therapy evaluation; immunosuppressive; lung transplantation; oral administration; pharmacokinetics; sirolimus; transplant rejection

This study of SDZ RAD was a randomized, double-blind, stratified(to primary diagnosis of pancreatic insufficient cystic fibrosis and non cystic fibrosis), crossover trial designed to test the tolerability, safety, pharmacokinetics, pharmacodynamics, and metabolism of SDZ RAD in stable lung and heart/lung transplant recipients. Trial participants received two different single oral doses of SDZ RAD (0.035 and 0.1 mg/kg, up to a maximum of 2.5 and 7.5 mg respectively). There was a washout period of approximately 15 days between the two administrations of SDZ RAD.

SDZ RAD研究是一项随机、双盲、分层(主要诊断为胰腺囊性纤维化不足和非囊性纤维化)的交叉试验，旨在测试SDZ RAD在稳定的肺和心/肺移植受者中的耐受性、安全性、药代动力学、药效学和代谢。试验参与者接受了两种不同的单次口服SDZ RAD(0.035和0.1 mg/kg，最大分别为2.5和7.5 mg)。SDZ RAD的两个管理部门之间有大约15天的冲销期。