BIOAVAILABILITY OF URSOCARB VS ACTIGALL IN CHRONIC CHOLESTATIC LIVER DISEASE

URSOCARB 与 ACTIGALL 在慢性胆汁淤积性肝病中的生物利用度

• 批准号: 6414977
• 负责人: WILLIAM F BALISTRERI
• 金额: $ 2.85万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6414977
• 关键词: chenodeoxycholate; cholestasis; chronic disease /disorder; clinical research; cystic fibrosis; human subject; human therapy evaluation; liver disorder chemotherapy; metabolism disorder chemotherapy; pharmacokinetics; ursodeoxycholate

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.

本研究的目的是比较聚合物涂层和缓冲UDCA(URSOCARB)和ACTIGALL在胆汁中UDCA的浓缩百分比、UDCA在血清中的比例和浓度的生物利用度，并比较这两种治疗方法在囊性纤维化和慢性肝病患者中的结果差异。在ACTIGALL每天15-30毫克/公斤(分两次给药)治疗四周后，受试者将采集胆汁样本(串试验)、血液和尿液样本。然后受试者将有24小时的洗脱期，并被切换到URSOCARB，每天15-30毫克/公斤(分两次给药)。在四周的治疗结束时，受试者将进行胆汁样本(串试验)、血液和尿液采集。胆汁样本将被分析UDCA的浓缩程度。将测量血清和尿液排泄量；UDCA肾排出量的增加将支持UDCA在肠道中的更大溶解度增加吸收和生物利用度的论点。