BIOAVAILABILITY OF URSOCARB COMPARED TO ACTIGALL IN LIVER DISEASE AND CF

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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.