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目的研究缬沙坦分散片在健康人体内的药动学,评价两种制剂的生物等效性。方法采用随机自身交叉双周期设计方法,将20例健康男性受试者随机分为2组,分别单次交叉口服缬沙坦受试制剂或参比制剂80mg,采用高效液相色谱-荧光检测法测定血浆中缬沙坦的浓度,计算其药动学参数和相对生物利用度,评价两制剂的生物等效性。结果受试制剂和参比制剂缬沙坦药代动力学参数:Cmax分别为(2536±1293)ng·mL-1和(2457±1413)ng·mL-1,tmax分别为(2.5±1.1)h和(2.3±0.7)h,t1/2分别为(5.9±1.8)h和(5.8±1.1)h,AUC0～30h分别为(14984±7155)ng.h.mL-1和(14390±7040)ng.h.mL-1。受试制剂的相对生物利用度为(115.6±52.5)%。结论缬沙坦的两制剂具有生物等效性。
Objective To study the pharmacokinetics of valsartan dispersible tablets in healthy volunteers and to evaluate the bioequivalence of the two preparations. Methods Twenty patients with healthy male subjects were randomly divided into two groups by random cross-cycle design. Oral valsartan test preparations or reference preparations 80mg were given orally, respectively. High-performance liquid chromatography-fluorescence detection The concentration of valsartan in plasma was determined, the pharmacokinetic parameters and relative bioavailability were calculated, and the bioequivalence of the two preparations was evaluated. Results The pharmacokinetic parameters of valsartan were (2536 ± 1293) ng · mL-1 and (2457 ± 1413) ng · mL-1, respectively, and the tmax were (2.5 ± 1.1) h and (2.3 ± 0.7) h, t1 / 2 were (5.9 ± 1.8) h and (5.8 ± 1.1) h respectively, while AUC0-30h were (14984 ± 7155) ng.h.mL- 1 and (14390 ± 7040) ) ng.h.mL-1. The relative bioavailability of the test preparation was (115.6 ± 52.5)%. Conclusion The two formulations of valsartan have bioequivalence.