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目的:研究2种坎地沙坦酯制剂的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服坎地沙坦酯片(受试制剂)和坎地沙坦酯胶囊(参比制剂),以高效液相色谱法测定血药浓度,3p97软件计算药动学参数与相对生物利用度。结果:受试制剂与参比制剂的Cmax分别为(276.785±28.957)、(269.118±30.116)ng.mL-1,tmax分别为(4.12±0.79)、(3.93±0.87)h,t1/2分别为(8.63±1.04)、(9.06±1.14)h,AUC0～48分别为(2589.248±306.674)、(2438.946±313.259)ng.h.mL-1,AUC0～∞分别为(2613.276±309.460)、(2493.636±324.491)ng.h.mL-1,受试制剂的相对生物利用度为(104.80±16.48)%。结论:2种制剂具有生物等效性。
Objective: To study the bioequivalence of two kinds of candesartan cilexetil in human body. Methods: Twenty healthy male volunteers were randomized to receive oral candesartan cilexetil (test preparation) and candesartan cilexetil acetate (reference preparation). Plasma concentrations were determined by high performance liquid chromatography (HPLC). 3p97 software Pharmacokinetic parameters and relative bioavailability were calculated. Results: The Cmax of test preparation and reference preparation were (276.785 ± 28.957) and (269.118 ± 30.116) ng.mL-1, respectively, and the tmax were 4.12 ± 0.79 and 3.93 ± 0.87 h (AUC0 ~ 48) were (2689.248 ± 306.674), (2438.946 ± 313.259) ng.h.mL-1 and AUC0 ~ ∞ were (2613.276 ± 309.460) and 2493.636 ± 324.491) ng.h.mL-1, the relative bioavailability of the test preparation was (104.80 ± 16.48)%. Conclusion: The two preparations are bioequivalent.