左旋多巴片在健康人体的生物等效性

目的评价2种左旋多巴片(抗震颤麻痹药)在健康人体内的生物等效性。方法 18名健康男性受试者随机交叉给药,分别单次口服左旋多巴片的试验药物或对照药物250 mg,用高效液相色谱法测定左旋多巴的血药浓度,计算2种药物的药代动力学参数,并评价其生物等效性。结果口服左旋多巴片试验药物及对照药物的主要药代动力学参数:t1/2分别为(1.06±0.31),(1.02±0.40)h;Tmax分别为(0.53±0.39),(0.54±0.37)h;Cmax分别为(1.69±0.66),(1.61±0.68)μg.mL-1;AUC0-t分别为(2.00±0.64),(1.85±0.50)μg.h.mL-1;AUC0-∞分别为(2.10±0.64),(1.95±0.55)μg.h.mL-1。试验药物相对于对照药物的平均相对生物利用度F值:AUC0-t为(110.9±33.1)%,AUC0-∞为(111.1±32.4)%。结论 2种左旋多巴片生物等效。

Bioequivalence of levodopa tablets in healthy volunteers

Objective To study the pharmacokinetics and bioequivalence of two levodopa tablets in healthy volunteers.Methods A single oral dose of 250 mg levodopa test and reference tablets were administered to eighteen male healthy volunteers in a randomized crossover method.Serum levodopa concentration was determined by a HPLC method.The pharmacokinetic parameters were calculated to evaluate the bioequivalence of these two preparations.Results The main pharmacokinetic parameters of levodopa test and reference tablets were as follows: t1/2 were(1.06±0.31) and(1.02±0.40) h;Tmax were(0.53±0.39) and(0.54±0.37) h;Cmax were(1.69±0.66) and(1.61±0.68) μg·mL-1;AUC0-t were(2.00±0.64) and(1.85±0.50) μg·h·mL-1;AUC0-∞ were(2.10±0.64) and(1.95±0.55) μg·h·mL-1,respectively.The average relative bioavailability were(110.9±33.1)% for AUC0-t and(111.1±32.4)% for AUC0-∞.Conclusion The two preparations of levodopa are bioequivalent.