Autor:innen:
Jürgen Drewe, Romanshorn (Switzerland)
Catherine Zahner, Romanshorn (Switzerland)
Esther Kruttschnitt, Romanshorn (Switzerland)
Julia Uricher, Romanshorn (Switzerland)
Michael Lissy, Neu-Ulm (Germany)
Martin Hirsch, Neu-Ulm (Germany)
Simon Nicolussi, Romanshorn (Germany)
Stephan Krähenbühl, Basel (Switzerland)
Hypericum perforatum L. (St. John’s wort) is used to treat mild-to-moderate depression. Its potential safety risks are pharmacokinetic drug interactions via cytochrome P450 enzymes and P-glycoprotein, presumably caused by hyperforin. In a phase I, open-label, non-randomized, single-sequence study, the low-hyperforin Hypericum extract Ze 117 was investigated using a drugs cocktail in 20 healthy volunteers. No pharmacokinetic interactions of Ze 117 were observed for CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP3A4 and P-glycoprotein. AUC and Cmax of the used probe drugs showed 90%-confidence intervals of the geometric mean ratios of the drugs taken together with Ze 117 vs. probe drug alone well within the predefined bioequivalence range of 80% to 125%.
Though Ze 117 did not induce dextromethorphan metabolism by CYP2D6, it weakly increased dextromethorphan AUC ratio (mean 147.99, 95% CI 126.32-173.39) but not the corresponding metabolic ratio. Ze 117 does not show clinically relevant pharmacokinetic interactions with important CYPs and P-glycoprotein.