Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis

Exclusion Criteria

• •1. Cirrhotic stage of chronic liver disease (Class A-C by Child-Pugh).
• •2. Hyperbilirubinemia more than 100 µmol/l.
• •3. GGTP level is more than 10 upper normal limits.
• •4. History of autoimmune liver disease.
• •5. Acute viral hepatitis (B, C, D).
• •6. Any somatic diseases in the stage of decompensation.
• •7. Regular use by the patient of medications prohibited in within the framework of this study, within 4 weeks before inclusion in the study and at throughout this study.
• •8. Hypersensitivity and/or intolerance to any component of the study drug /comparator drug.
• •9. Pregnancy or lactation period.
• •10. Peptic ulcer of the stomach and/or duodenum, and/or erosive gastritis in the acute phase.
• •11. History of chronic kidney disease C4-C5 and/or known glomerular filtration rate \<30 ml/min.
• •12. Regular intake of more than 2 units. alcohol per week.
• •13. Unstable angina.
• •14. Myocardial infarction 3 months or less before the expected date of inclusion.
• •15. Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
• •16. History of cancer within the last 5 years, mental illness, HIV infection, tuberculosis, drug addiction.
• •17. Mental, physical and other reasons that prevent the patient adequately behave and correctly fulfill the conditions of the study protocol.