中国临床药理学杂志2012，Vol.28Issue(2)：125-127,157,4.
泛昔洛韦片在中国健康人体的生物等效性
Bioequivalence of famciclovir tablets in Chinese healthy volunteers
郭韶洁 1王淑民 1武峰 1李嘉静 1周辉 1赵秀丽1
作者信息
- 1. 首都医科大学附属北京同仁医院Ⅰ期临床试验研究室,北京100730
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalent of test tablet and reference tablet of famciclovir in Chinese volunteers. Method In self -control and two - way crossover design, 20 healthy male volunteers were divided into two groups at random. Each subject was given 500 mg of the test tablet and reference tablet of famciclovir respectively at single dose. Plasma concentrations of penciclovir ( active metabolin) were determined by HPLC method. The pharmacokinetic parameters were calculated with DAS statistic software, the bioequivalent of famciclovir tablet evaluated as well. Results The main pharmacokinetic parameters of famciclovir test tablet and reference tablet were as follows: C^ ( 2. 60 ± 0. 53 ) , ( 3. 50 ±0.84) mg·L-1; Tmax,(0. 99 ±0.45), (2.50±0.23) h ; t1/2(2.52 ±0.32),(2. 50 ±0. 23) h; AUC0_t(9. 10 ±1.61), (9.61 ±1.70)mg ? H ? L~ , respectively. The relative bioavailability of famciclovir test tablet was (95. 29 ± 9. 85)% . Conclusion The test tablet and reference tablet of famciclovir were bioequivalent.关键词
泛昔洛韦/喷昔洛韦/高效液相色谱法/生物等效性Key words
famciclovir/penciclovir/HPLC/bioequivalent分类
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郭韶洁,王淑民,武峰,李嘉静,周辉,赵秀丽..泛昔洛韦片在中国健康人体的生物等效性[J].中国临床药理学杂志,2012,28(2):125-127,157,4.
