THE EFFECTS OF MULTIPLE INGESTION OF TEN-CHA ON PHARMACOKINETICS AFTER SINGLE ORAL ADMINISTRATION OF SIMVASTATIN

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In a previous study, we examined the influence of several herbal teas including Ten-cha on drug metabolism using human microsomes. The study showed that Ten-cha potently inhibited cytochrome P450 3A4 (CYP3A4) activity. In the present study we investigated the effects of Ten-cha on the pharmacokinetics (PK) of simvastatin. A randomized, two-way crossover design was used at an interval of 1 week. Eight healthy male volunteers were administrated a dose of 10 mg simvastatin with either 200 mL of Ten-cha or water, and blood samples were collected to determine PK parameters. Ten-cha or water was ingested 3 times a day before drug administration and once an hour after dose. The ratios of geometric means of the AUC0-24, and the Cmax of Ten-cha to water treatment were 0.94 and 1.29, respectively. In addition the differences of arithmetic means between Tencha and water treatment of t1 2 and CL /F were 0.83 h and 37.5 mL/h, respectively. There were no significant differences of PK parameters between the Ten-cha treatment and water treatment. Even a maximum change of PK parameters exhibited by a volunteer in this study was no more than three-fold. It was suggested that there is little possibility of the occurrence of an adverse event caused by the interaction between Ten-cha and simvastatin under the condition we investigated. However, food and/or health supplement consumption in the responsibility of the user, it is impossible to deny the possibility of the incidence of a clinically important drug vs. Ten-cha interaction. Further interaction studies with Ten-cha are needed under different conditions at various doses, frequency and timing of Ten-cha ingestion, as well as with co-administration of other medicines.

THE EFFECTS OF MULTIPLE INGESTION OF TEN-CHA ON PHARMACOKINETICS AFTER SINGLE ORAL ADMINISTRATION OF SIMVASTATIN

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