Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis

Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis

The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).

Inclusion Criteria:

• Negative pregnancy
• Signed informed consent
• Histologically proven non-cirrhotic liver disease

Exclusion Criteria:

• histologically proven cirrhosis
• PBC stage II+IV
• Positive HIV serology