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

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:
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
SDZ RAD的研究是一项随机、双盲、分层(初步诊断为胰腺不完全性囊性纤维化和非囊性纤维化)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剂量的SDZ RAD(分别为0.035和0.1 mg/kg,最大剂量分别为2.5和7.5 mg)。两次给药之间约有15天的洗脱期。
英文摘要
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.
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PHARMACODYNAMIC MONITORING OF MYCOPHENOLATE MOFETIL TREATMENT
  • 批准号:
    6486092
  • 项目类别:
  • 资助金额:
    $13.47万
  • 财政年份:
    2000
  • 负责人:
    RANDALL E MORRIS
  • 依托单位:
TWO DOSES STUDY TO COMPARE THE SAFETY OF SDZ RAD IN HEART/LUNG TRANSPLANT
  • 批准号:
    6486057
  • 项目类别:
  • 资助金额:
    $13.47万
  • 财政年份:
    2000
  • 负责人:
    RANDALL E MORRIS
  • 依托单位:
TWO DOSES STUDY TO COMPARE THE SAFETY OF SDZ RAD IN HEART/LUNG TRANSPLANT
  • 批准号:
    6219377
  • 项目类别:
  • 资助金额:
    $0.06万
  • 财政年份:
    1998
  • 负责人:
    RANDALL E MORRIS
  • 依托单位:
TWO DOSES STUDY TO COMPARE THE SAFETY OF SDZ RAD IN HEART/LUNG TRANSPLANT
  • 批准号:
    6115068
  • 项目类别:
  • 资助金额:
    $4.03万
  • 财政年份:
    1998
  • 负责人:
    RANDALL E MORRIS
  • 依托单位:
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