In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis

Exclusion Criteria

• •Known hypersensitivity to probe substances or any excipient of the drug formulation.
• •Ongoing or past treatment with another investigational drug within 30 days prior to screening.
• •Concomitant treatment with drugs that inhibit or induce CYP3A4, CYP2D6, CYP2C9, CYP2C19, CYP2B6 and CYP1A2 function (in the opinion of investigator).
• •Actual infection
• •Severe heart failure (NYHA IV).
• •Actual alcohol or drug abuse
• •Positive results from urine drug screen at screening.
• •Excessive caffeine consumption, defined as \>800 mg per day at screening\*.
• •Subjects unwilling to stop consumption of alcoholic- and caffeine-containing beverages on study days until after the last sampling time-point of the study period.
• •Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450 (e.g. grapefruit juice)
• •Loss of 250 ml or more of blood within 3 months prior to screening.
• •Pregnant or lactating women
• •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• •Legal incapacity or limited legal capacity at screening. \*100 mg caffeine is approximately 1'000 ml Coca Cola®, 2½ espresso cups or 1 cup of strong coffee.