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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Ursodeoxycholic Acid

Criteria

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