Drug Interaction Study Clinical Trial
Official title:
Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers
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.
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