NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Mechanism of Action
CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large "first-pass" effect) where it is…
Pharmacologic Class:
Bile Acid
Clinical Trials (2)
Ursodiol Tablets 500 mg Under Fasting Conditions
Started Dec 2006
80 enrolled
Healthy
Ursodiol 500 mg Tablets Under Fed Conditions
Started Sep 2006
92 enrolled
Healthy