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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。
Objective To evaluate the bioequivalence of 2 levodopa tablets (antiparkinsonism) in healthy volunteers. Methods Eighteen healthy male subjects were randomized to receive oral administration of levodopa tablets of test drug or control drug 250 mg respectively. The plasma concentrations of levodopa were determined by high performance liquid chromatography (HPLC) Pharmacokinetic parameters and their bioequivalence were evaluated. Results The main pharmacokinetic parameters of oral levodopa tablets and control drugs were as follows: t1 / 2 were (1.06 ± 0.31) and (1.02 ± 0.40) h respectively; Tmax was (0.53 ± 0.39) and ) h and Cmax were (1.69 ± 0.66) and (1.61 ± 0.68) μg.mL-1, respectively; AUC0-t were (2.00 ± 0.64) and (1.85 ± 0.50) μg.h.mL- (2.10 ± 0.64) and (1.95 ± 0.55) μg.h.mL-1, respectively. The mean relative bioavailability F of the test drug relative to the control drug: AUC0-t was (110.9 ± 33.1)% and AUC0-∞ was (111.1 ± 32.4)%. Conclusions Two levodopa tablets are bioequivalent.