Effects of cholestasis on pharmacokinetics
Withdrawn
- Conditions
- icterusjaundice10019654
- Registration Number
- NL-OMON38889
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
- Bilirubin > 50 mmol/l, caused by posthepatic biliary obstruction
- Endoscopic Retrograde CholangioPancreatography (ERCP) has been scheduled
- > 18 years old
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in area under the plasma concentration versus time curve (AUC)<br /><br>for each drug following the oral administration of the drug cocktail prior to<br /><br>ERCP in patients with cholestasis (A1) in comparison with the control situation<br /><br>2 weeks after successful drainage has been achieved (A2). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The correlation between changes in AUC of the drugs and changes in AUC of<br /><br>postprandial bile acids before and after biliary drainage. </p><br>