Pharmacokinetic interactions between atorvastatin and traditional herbal medicines, Banhabaekchulcheonmatang and Hwangryeonhaedoktang in healthy volunteers

초록

Background: Banhabaekchulcheonmatang (BBCT) and Hwangryeonhaedoktang (HRHDT) are traditional herbal medicines widely used in East Asia to treat post-stroke sequelae. This study evaluated the effects of BBCT and HRHDT on the pharmacokinetics of atorvastatin, a drug commonly prescribed for secondary stroke prevention. Methods: An open-label, randomized, three-period, two-sequence trial was conducted in 14 healthy Korean participants. In the first period, participants received a single 40 mg dose of atorvastatin. In subsequent periods, BBCT or HRHDT was administered three times daily for five days, followed by co-administration with atorvastatin on day 6. Plasma concentrations of atorvastatin and its active metabolites were measured, and pharmacokinetic parameters were determined using non-compartmental analysis. Results: Co-administration of BBCT reduced the maximum plasma concentration (Cmax) of atorvastatin by 24% without affecting the area under the plasma concentration-time curve (AUC), whereas HRHDT decreased atorvastatin Cmax, AUClast, and AUCinf by 46.7%, 22.6%, and 21.1%, respectively. BBCT or HRHDT co-administration also reduced the Cmax, AUClast, and AUCinf of 2-hydroxy atorvastatin by 30.2% and 52.7%, 14.9% and 35.9%, and 14.8% and 32.0%, respectively. Conclusion: Co-administration of atorvastatin with BBCT or HRHDT resulted in a weak-to-moderate reduction in systemic exposure to atorvastatin and 2-hydroxy atorvastatin, suggesting that careful monitoring may be warranted during concomitant use. Trial registration: Clinical Research Information Service (CRIS), Republic of Korea (KCT0008735). © 2026

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