BIOAVAILABILITY OF URSOCARB COMPARED TO ACTIGALL IN LIVER DISEASE AND CF

URSOCARB 与 ACTIGALL 在肝病和 CF 中的生物利用度比较

• 批准号: 7374482
• 负责人: WILLIAM F BALISTRERI
• 金额: $ 0.06万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374482
• 关键词: BIOAVAILABILITY; URSOCARB; COMPARED; ACTIGALL; LIVER

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The objective of this study is to determine the bioavailability of a polymer coated and buffered UDCA (URSOCARB) as compared to ACTIGALL on percent UDCA enrichment in the bile, proportion and concentration of UDCA in serum, and compare the differences between the results for these two treatments in patients with cystic fibrosis and chronic liver disease. Following a four-week treatment with ACTIGALL at 15-30 mg/kg/day (given in two divided doses), the subjects will have samples of bile (string test), blood, and urine collected. The subjects will then have a 24 hour wash-out period, and be switched to URSOCARB at 15-30 mg/kg/day (given in two divided doses). At the end of four weeks of treatment, the subjects will have samples of bile (string test), blood and urine collected. The samples of bile will be analyzed for the degree of UDCA enrichment. Serum and urinary excretion will be measured; enhanced renal output of UDCA will support the contention that greater solubility of UDCA in the intestine increases absorption and bioavailability. Subjects have the opportunity to continue to receive URSOCARB as approved for compassionate use upon completion of the initial cross-over study protocol.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是确定聚合物包被和缓冲UDCA （URSOCARB）的生物利用度，与ACTIGALL相比，UDCA在胆汁中的富集百分比，UDCA在血清中的比例和浓度，并比较这两种治疗在囊性纤维化和慢性肝病患者中的结果差异。在以15- 30mg /kg/天（分两次给药）的ACTIGALL治疗四周后，将收集受试者的胆汁（串状试验）、血液和尿液样本。然后受试者将有24小时的洗脱期，并切换到URSOCARB，剂量为15-30 mg/kg/天（分两次给药）。在四周的治疗结束时，受试者将收集胆汁（串珠试验）、血液和尿液样本。胆汁样品将被分析UDCA富集程度。测定血清和尿液排泄；UDCA肾输出量的增加将支持UDCA在肠中的溶解度增加吸收和生物利用度的论点。在完成初始交叉研究方案后，受试者有机会继续接受经批准用于同情使用的URSOCARB。