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Research ArticleArticle

Drug Cocktail Interaction Study on the Effect of the Orally Administered Lavender Oil Preparation Silexan on Cytochrome P450 Enzymes in Healthy Volunteers

Oxana Doroshyenko, Dennis Rokitta, Gregor Zadoyan, Stephan Klement, Sandra Schläfke, Angelika Dienel, Thomas Gramatté, Hendrik Lück and Uwe Fuhr
Drug Metabolism and Disposition May 2013, 41 (5) 987-993; DOI: https://doi.org/10.1124/dmd.112.050203
Oxana Doroshyenko
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Dennis Rokitta
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Gregor Zadoyan
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Stephan Klement
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Sandra Schläfke
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Angelika Dienel
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Thomas Gramatté
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Hendrik Lück
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Uwe Fuhr
ITECRA GmbH & Co. KG, Cologne, Germany (O.D., G.Z., H.L., U.F.); Department of Pharmacology, Clinical Pharmacology Unit; University Hospital, University of Cologne, Cologne, Germany (D.R., G.Z., U.F.); Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (S.K., S.S., A.D.); and Drug Development Consulting, Dresden, Germany (T.G.)
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Abstract

This cocktail study evaluated the interaction potential of the oral lavender oil preparation silexan with major P450 (cytochrome P450) enzymes. Subjects and Methods: Sixteen healthy male or female Caucasians completed this double-blind, randomized, 2-fold crossover study. Silexan (160 mg) or placebo were administered once daily for 11 days. Additionally, on day 11 of both study periods, 150 mg caffeine (CYP1A2), 125 mg tolbutamide (CYP2C9), 20 mg omeprazole (CYP2C19), 30 mg dextromethorphan-HBr (CYP2D6), and 2 mg midazolam (CYP3A4) were administered orally. Formal interaction was excluded if the 90% confidence interval (CI) for the silexan over placebo ratios for phenotyping metrics (primary: AUC0–t) was within a 0.70–1.43 range. Results: According to the AUC0–t comparisons, silexan had no relevant effect on CYP1A2, 2C9, 2D6, and 3A4 activity. Secondary phenotyping metrics confirmed this result. Mean ratios for all omeprazole-derived metrics were close to unity. The 90% CI for the AUC0–t ratio of omeprazole but not for omeprazole/5-OH-omeprazole plasma ratio 3 hours post-dose or omeprazole/5-OH-omeprazole AUC0–t ratio (secondary CYP2C19 metrics) was above the predefined threshold of 1.43, probably caused by the inherent high variability of omeprazole pharmacokinetics. Silexan and the phenotyping drugs were well tolerated. Repeated silexan (160 mg/day) administration has no clinically relevant inhibitory or inducing effects on the CYP1A2, 2C9, 2C19, 2D6, and 3A4 enzymes in vivo.

Footnotes

    • Received November 19, 2012.
    • Accepted February 7, 2013.
  • In adherence to the guidelines of the International Committee of Medical Journal Editors, it is declared that this study is work for hire supported by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany (sponsor). S.K., S.S., and A.D. are employees of Dr. Willmar Schwabe GmbH & Co. K.G. and T.G. received honoraria from Schwabe. No further conflict of interest is to be declared.

  • dx.doi.org/ 10.1124/dmd.112.050203.

  • Copyright © 2013 by The American Society for Pharmacology and Experimental Therapeutics
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Drug Metabolism and Disposition: 41 (5)
Drug Metabolism and Disposition
Vol. 41, Issue 5
1 May 2013
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Research ArticleArticle

Cocktail Interaction Study on Silexan in Healthy Subjects

Oxana Doroshyenko, Dennis Rokitta, Gregor Zadoyan, Stephan Klement, Sandra Schläfke, Angelika Dienel, Thomas Gramatté, Hendrik Lück and Uwe Fuhr
Drug Metabolism and Disposition May 1, 2013, 41 (5) 987-993; DOI: https://doi.org/10.1124/dmd.112.050203

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Research ArticleArticle

Cocktail Interaction Study on Silexan in Healthy Subjects

Oxana Doroshyenko, Dennis Rokitta, Gregor Zadoyan, Stephan Klement, Sandra Schläfke, Angelika Dienel, Thomas Gramatté, Hendrik Lück and Uwe Fuhr
Drug Metabolism and Disposition May 1, 2013, 41 (5) 987-993; DOI: https://doi.org/10.1124/dmd.112.050203
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