非诺贝特胶囊(微粒化)人体生物利用度研究

目的评价非诺贝特胶囊(微粒化)2种制剂的生物等效性。方法24名健康男性志愿者单剂量随机交叉口服非诺贝特胶囊(微粒化)受试制剂160mg与参比制剂200mg,采用高效液相色谱法测定血药浓度,计算药动学参数和相对生物利用度。结果受试制剂与参比制剂的tmax分别为(3.91±1.00)、(3.74±0.86)h,Cmax分别为(10.33±3.26)、(10.61±2.79)μg/ml,AUC0~72分别为(173.54±56.04)、(176.69±47.13)(μg.h)/ml,t1/2分别为(22.25±3.78)、(23.19±3.71)h,受试制剂的相对生物利用度为(97.80±14.32)%。结论2种制剂具有生物等效性。

Bioavailability of Lipantil Capsule (Micronized) in Human Body

OBJECTIVE: To study bioequiavailability of two preparations of Lipantil capsule micronized in human body. METHODS: A total of 24 male healthy volunteers were assigned to receive lipantil capsules (test preparation) 160mg and common fenofibrate capsules (reference substance) 200mg in a randomized crossover way. Blood concentrations of the subjects were determined by HPLC and pharmacokinetic parameters and relative bioavailability were computed as well. RESULTS: The pharmacokinetic parameters of lipantil capsule vs. common fenofibrate capsule were as follows: tmax was (3.91±1.00) h vs. (3.74±0.86) h,Cmax was (10.33±3.26) μg/ml vs. (10.61±2.79) μg/ml, AUC0～72 was (173.54±56.04)(μg·h)/ml vs. (176.69±47.13) (μg·h)/ml,t1/2 was (22.25±3.78) h vs. (23.19±3.71) h. The relative bioavailability of lipantil capsule was (97.80±14.32) %. CONCLUSION: The two preparations nad the bio equiavailability.