BIOAVAILABILITY OF URSOCARB VS ACTIGALL IN CHRONIC CHOLESTATIC LIVER DISEASE

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。

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.