Background. Bojungikki-tang (BJIKT) is a widely used traditional herbal formula in China, Japan, and Korea. There have been\nreports that several herbs among BJIKT have interactions with antiplatelet drugs, such as aspirin. This study aimed to assess\nwhether BJIKT interacts with aspirin in terms of pharmacokinetics (PK) and pharmacodynamics (PD) in healthy subjects and\nischemic stroke patients. Methods.The phase I interaction trial was a randomized, open-label, crossover study of 10 healthy male\nsubjects, and the phase III interaction trial was a randomized, placebo-controlled, parallel study of 43 ischemic stroke patients.\nEach participant randomly received aspirin + BJIKT or aspirin + placebo. For PK analysis, plasma acetyl salicylic acid (ASA) and\nsalicylic acid (SA) were evaluated, and, for PD analysis, platelet aggregation and plasma thromboxane B2 (TxB2) were measured.\nResults. In the PK parameters, mean area under curve, maximum concertation, and peak concentration time of ASA and SA were\nnot different between two groups in healthy subjects and ischemic stroke patients. In the PD profiles, TxB2 concentrations and\nplatelet aggregation were not affected by coadministration of BJIKT in healthy subjects and ischemic stroke patients. Conclusions.\nThese results suggest that coadministration of BJIKT with aspirin may not result in herb-drug interaction.
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