法莫替丁对多潘立酮在健康人体药代动力学的影响

Effect of famotidine on pharmacokinetics of domperidone in healthy volunteers after a single oral administration

目的观察法莫替丁对多潘立酮药代动力学的影响。方法随机分组,10名健康志愿者未服和服用法莫替丁后单剂量口服多潘立酮10mg,用LC/MS/MS测定血药浓度,DAS软件计算药代动力学参数,t检验、非参数检验比较主要药代动力学参数。结果未服和服用法莫替丁后单剂量口服多潘立酮的血药浓度时间曲线均符合二室模型,达峰时间tmax分别为0.63±0.36、1.50±0.97h,峰浓度Cmax分别为9.91±5.45、4.30±5.01μg·L-1,曲线下面积AUC0-tn分别为39.57±10.46、32.43±9.61μg·h·L-1。服用法莫替丁后,多潘立酮的达峰时间延长,血药浓度时间曲线下面积减少,峰浓度降低,且均有统计学意义。结论在健康人体内,法莫替丁对多潘立酮的药代动力学参数影响显著。

AIM： To study the effect of famotidine on the pharmacokinetics of domperidone. METHODS： A single oral dose of domperidone 10 mg was given to 10 healthy volunteers under the condition of untaking or taking famotidine in a randomized, cross-over study. Plasma domperidone concentration was determined by a validated LC/MS/MS method. Pharmacokinetic parameters were calculated by DAS software and compared by t tests. RESULTS： The concentration-time curve of domperidone with untaking or taking famotidine was conformed to a two-compartment model. Under untaking and taking famotidine conditions, the main pharmacokinetic parameters,tmax, Cmax and AUC0-tn were 0.63 ± 0.36 and 1.50 ± 0.97 h, 9.91±5.45 and 4.30±5.01 μg·L^-1, 39.57 ± 10.46 and 32.43 ± 9.61μg·h·L^-1 respeetively. The absorption of domperidone was delayed, and the peak eoneentration and area under eurve were redueed signifieantly when famotidine was taken. CONCLUSION： Famotidine had a signifieant effeet on the pharmaeokineties of domperidone after a single oral dose in healthy volunteer.