厄贝沙坦胶囊在健康志愿者体内的药代动力学及相对生物利用度研究。
Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers.
作者信息
Gu Shifen, Chen Hui, Qiu Yinghai, Shi Shaojun, Zeng Fandian
机构信息
Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030.
出版信息
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。
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