Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Status:
Recruiting
Trial end date:
2025-06-15
Target enrollment:
Participant gender:
Summary
Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the
effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders,
non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention,
occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of
the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a
solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic
cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug
REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as
REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study
is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy
of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in
patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company