中国临床药理学与治疗学2009，Vol.14Issue(7)：794-798,5.
坎地沙坦酯片和胶囊在健康人体的药代动力学和生物等效性
Pharmacokinetics and bioequivalence of candesartan cilexetic tablet and capsule in healthy volunteers
俞佳 1马珂 1祁金文 2金戈 1王燕 1方顺干 1李功华 1谢丹1
作者信息
- 1. 浙江省人民医院药剂科,杭州,310014,浙江
- 2. 浙江大学医学院附属邵逸夫医院药剂科,杭州,310016,浙江
- 折叠
摘要
Abstract
To investigate the pharmacoki-netics and bioequivalence of candesartan cilexetic tablets, capsules and imported tablets in healthy volun-teers. METHODS: A single oral dose 16 mg of three formulations was randomly given to 18 healthy volun-teers in a three cycle duplex 3×3 latin square cross-over design. The concentration of candesartan in plas-ma , which is a major metabolite of candesartan cilexet-ic, was determined by HPLC-FLD at different times. The pharmacokinetics parameters were calculated and the bioequivalence of three formulations were evaluated by DAS program. RESULTS: The main pharmacoki-netic parameters of candesartan cilexetic tablets, cap-sules and imported tablets were as follows: t_(max) were (4.6±0.9),(4.6±1.3) and (4.4±0.9) h, t_(1/2) were(8.8±1.9), (8.3 ± 1.9), (8.5± 1.8) h,C_(max) were( 170 ± 61) , ( 155 ± 75) and (171 ± 77) ng/mL, AUC_(0-36) were( 1762 ± 576), (1684 ± 600) and (1808 ± 662) ng·mL~(-1)·h, AUC_(0-∞) were ( 1886 ± 616),(1776 ±600) and (1913 ± 694) ng·mL~(-1)·h. The relative bioavailability of tested tablets and capsules were 97.75% and 93.11%. CONCLUSION: The two tested formulations are bioequivalent with reference formulation.关键词
坎地沙坦酯/坎地沙坦/高效液相色谱-荧光法/药代动力学/生物等效性Key words
candesartan cilexetic/ candesartan/HPLC-FLD/ pharmacokinetics/ bioequivalence分类
医药卫生引用本文复制引用
俞佳,马珂,祁金文,金戈,王燕,方顺干,李功华,谢丹..坎地沙坦酯片和胶囊在健康人体的药代动力学和生物等效性[J].中国临床药理学与治疗学,2009,14(7):794-798,5.
