环泊酚注射液与利福平胶囊的药物相互作用研究

Drug interaction study of ciprofol injection and rifampicin capsules

目的通过研究环泊酚注射液与CYP2B6酶强诱导剂利福平的药物相互作用(DDI),评估环泊酚在代谢过程中可能受到的潜在CYP酶的影响。方法该研究是一项在健康受试者中进行的单中心、开放、随机、两阶段、两交叉临床研究。通过比较利福平胶囊对环泊酚注射液的药动学(PK)、药效学(PD)及安全性的影响,对环泊酚与利福平的DDI进行分析。结果与单用环泊酚注射液相比,稳态利福平对环泊酚AUC_(0-∞)、AUC_(0-inf)及C_(max)均无显著性影响;2组双频指数(BIS)AUC_(0-t)和BIS_(peak)几何均数比值的90%置信区间均在80.00%~125.00%。稳态利福平对环泊酚的药效(BIS值)及安全性和耐受性均无显著性的影响。结论环泊酚的PK参数、PD参数、安全性及耐受性指标均不受CYP2B6诱导剂利福平的影响。

AIM To evaluate the potential influence of CYP enzyme on the metabolism of ciprofol injection by studying the drug-drug interaction(DDI)between cypofol injection and CYP2B6 enzyme strong inducer rifampin.METHODS The study was a single-center,open-label,randomized,two-stage,two-crossover clinical trial in healthy subjects.By comparing the pharmacokinetics(PK),pharmacodynamics(PD)and safety of cipofol injection,the DDI between cipofol and rifampicin was analyzed.RESULTS Compared with ciprofol injection along,steady-state rifampin showed no significant influence on the AUC_(0-∞),AUC_(0-inf)and C_(max)of ciprofol.The 90%confidence intervals of the geometric mean ratios of BIS AUC_(0-t)and BIS_(peak)were within the range from 80.00%to 125.00%.Steady-state rifampin had no significant effect on the efficacy(BIS value),safety and tolerability of cypofol.CONCLUSION The pharmacokinetics,pharmacodynamics,safety and tolerability indexes of ciprofol are not affected by the CYP2B6 inducer rifampin.