2种坎地沙坦酯制剂的人体生物等效性研究

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。

Studies on the Bioequivalence of Two Candesartan Cilexetil Preparations

OBJECTIVE:To study the bioequivalence of two candesartan cilexetil preparations in healthy subjects.METH-ODS: A single dose of Candesartan Cilexetil tablets(test preparation) or Candesartan Cilexetil capsules(control preparation) was administrated to 20 healthy male volunteers in a randomized crossover way.The concentrations of Candesartan in serum were determined by HPLC.The pharmacokinetic parameters and bioequivalence were calculated with 3p97 program.RESUL- TS:The main pharmacokinetic parameters of the test and control preparation were as follows:Cmax were (276.785±28.957)and (269.118±30.116)ng·mL-1,tmax were (4.12±0.79) and (3.93±0.87)h,t1/2 were (8.63±1.04) and(9.06±1.14)h,AUC0～48 were (2 589.248±306.674) and (2 438.946±313.259)ng·h·mL-1,AUC0～∞ were (2 613.276±309.460) and (2 493.636± 324.491)ng·h·mL-1,respectively.The relative bioavailability of the test Candesartan Cilexetil tablets was(104.80±16.48)%.CONCLUSIONS:The two Candesartan Cilexetil preparations are bioequivalent.