icterus jaundice
Conditions
Interventions
This study consists of two study days. Subjects will receive a single
administration of a drug cocktail prior to (A1) and 2 weeks after (A2)
successful biliary drainage by ERCP. The drug cocktail co
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Bilirubin > 50 mmol/l, caused by posthepatic biliary obstruction - Endoscopic Retrograde CholangioPancreatography (ERCP) has been scheduled - > 18 years old
Exclusion criteria
Exclusion criteria: - Diabetes Mellitus (both type 1 and 2) - Cholangitis - If a significant change in use of medication after ERCP is to be expected - Use of omeprazole, warfarin, metoprolol, caffeine or midazolam (= medication of our probe cocktail) as standard treatment - Use of herbal medicine or medication that inhibits or induces CYP3A4/5, CYP2C9, CYP1A2, CYP2C19, CYP2D6
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in area under the plasma concentration versus time curve (AUC) for each drug following the oral administration of the drug cocktail prior to ERCP in patients with cholestasis (A1) in comparison with the control situation 2 weeks after successful drainage has been achieved (A2). | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between changes in AUC of the drugs and changes in AUC of postprandial bile acids before and after biliary drainage. | — |
Countries
Netherlands
Outcome results
None listed