This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.
Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions. The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA). A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
Nuvisan GmbH
Neu-Ulm, Germany
Area under the Plasma concentration versus time curve (AUC0-t)
Pharmacokinetic Parameter AUC0-t (mg\*h/L) of the probe drugs will be determined.
Time frame: 72 hours
Area under the Plasma concentration versus time curve (AUC0-inf)
Pharmacokinetic parameter (mg\*h/L) of the probe drugs and their metabolites will be determined.
Time frame: 72 hours
Peak Plasma Concentration (Cmax)
Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined.
Time frame: 72 hours
Elimination rate constant (Ke)
Pharmacokinetic Parameter (h\^-1) of the probe drugs and their metabolites will be determined.
Time frame: 72 hours
Elimination half life (t1/2)
Pharmacokinetic Parameter (h) of the probe drugs and their metabolites will be determined.
Time frame: 72 hours
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