Gallstone disease
Conditions
Interventions
Trade Name: Rimactan
Product Name: Rifampicin
Pharmaceutical Form: Tablet
Trade Name: Ursofalk
Product Name: Ursodeoxycholic acid
Pharmaceutical Form: Capsule, hard
Sponsors
Hanns-Ulrich Marschall
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Gallstone disease, scheduled for laparascopic cholecystectomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy and previous or ongoing liver, kidney, intestinal or metabolic diseases, as well as the use of medications known to affect liver function and metabolism, e.g. lipid or glucose lowering drugs, P450 enzyme inducers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of rifampicin in combination with ursodeoxycholic acid on detoxification and elimination mechanisms for biliary lipids. It was found before that rifampicin induces the expression of CYP3A4, MRP2 and UGT1A1, and that UDCA induced the expression of MDR3, MRP4 and BSEP but it is unknown whether these effects are still to be expected when both agents are administered in combination.;Secondary Objective: ;Primary end point(s): To study the effects of combined rifampicin and ursodeoxycholic acid on bile acid and bilirubin metabolism and detoxification by measuring hepatic gene and protein expression levels, and bile acids in bile, serum, and urine. | — |
Countries
Sweden
Outcome results
None listed