Gu Shifen, Chen Hui, Qiu Yinghai, Shi Shaojun, Zeng Fandian
Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030.
J Huazhong Univ Sci Technolog Med Sci. 2002;22(1):14-6. doi: 10.1007/BF02904777.
The pharmacokinetics and relative bioavailability were studied in 18 healthy volunteers. A single oral dose of 150 mg irbesartan capsule (test) or tablet (reference) was given to each volunteer according to a randomized 2-way crossover study. The concentrations in plasma were determined by HPLC-UV method. The main parameters of irbesartan capsules were: Cmax: 1.502 +/- 0.295 micrograms/ml, tmax: 1.44 +/- 0.34 h, t 1/2: 20.21 +/- 14.71 h, AUC0-t: 11.087 +/- 3.443 micrograms/ml-1.h. The relative bioavailability of capsule to tablet was (101.4 +/- 28.9)%. The results of statistical analysis showed that two formulations were bioequivalent.
在18名健康志愿者中研究了（药物的）药代动力学和相对生物利用度。根据随机双交叉研究，给每位志愿者单次口服150毫克厄贝沙坦胶囊（试验品）或片剂（参比品）。采用高效液相色谱-紫外检测法测定血浆中的浓度。厄贝沙坦胶囊的主要参数为：Cmax：1.502±0.295微克/毫升，tmax：1.44±0.34小时，t 1/2：20.21±14.71小时，AUC0-t：11.087±3.443微克/毫升-1·小时。胶囊相对于片剂的相对生物利用度为（101.4±28.9）%。统计分析结果表明两种制剂生物等效。
