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中国临床药理学与治疗学 ›› 2002, Vol. 7 ›› Issue (5): 437-439.

• 研究原著 • 上一篇    下一篇

国产格列美脲片剂在健康男性志愿者的生物等效性评价

王少华, 陈安进, 于宝东, 初晓, 石杰, 赵美玲   

  1. 青岛市立医院国家药品临床研究基地, 青岛 266011
  • 收稿日期:2002-03-30 修回日期:2002-07-24 发布日期:2020-11-26
  • 通讯作者: 王少华, 女, 主任药师, 研究生导师, 青岛市立医院国家药品临床研究基地副主任。主要从事临床药理学研究。Tel:0532-2836349 E-mai l:pharm@pubic.qd.sd.cn

Evaluation of bioequivalence of domestic glimepiride tablet in Chinese healthy male volunteers

WANG Shao-Hua, CHEN An-Jin, YU Bao-Dong, CHU Xiao, SHI Jie, ZHAO Mei-Ling   

  1. Nation Base of Drug Clinical Trial of Qingdao Municipal Hospital, Qingdao 266011
  • Received:2002-03-30 Revised:2002-07-24 Published:2020-11-26

摘要: 目的 以单剂量试验判定格列美脲片剂与参比胶囊剂的生物等效性。 方法 20 名健康男性志愿者随机分成两组, 采用3 mg 单剂量(口服) 交叉试验设计, 以高效液相法测定血药浓度, 以3p97 药代动力学程序求算, 等效性分析用双单侧t 检验。 结果 格列美脲片剂和参比胶囊剂的AUC(0-t) 分别为(1.23 ±0.19) 和(1.31 ±0.22) mg·h·L-1, AUC(0-inf)分别为(1.32 ±0.20) 和(1.45 ±0.24) mg·h·L-1,Cmax分别为(0.30 ±0.05) 和(0.30 ±0.06) mg·L-1,Tpeak分别为(2.43 ±0.29) 和(2.55 ±0.46) h, T1/2Ke分别为(6.9 ±2.5) 和(9.3 ±7.9) h。FAUC(0-t) =96.4 ±21.1, FAUC(0-inf) =93.7 ±20.7。 结论 格列美脲片剂和参比胶囊剂生物等效。

关键词: 格列美脲, 高效液相色谱, 生物等效性

Abstract: AIM: To compare the bioequivalence of glimepiride tables and capsules with a single dose. METHODS: Twenty Chinese healthy male volunteers were enrolled in a randomized crossover study with a single oral dose 3 mg of two formulations respectively.The blood drug concentration in serum was measured by HPLC, and the pharmacokinetic parameters were calculated by 3p97 software and compared by two one-side ttest. RESULTS: The parameters of the tables and the capsules were (1.23 ± 0.19) and (1.31 ± 0.22) mg·h·L-1at AUC(0 -t), (1.32 ±0.20) and (1.45 ± 0.24) mg·h·L-1 at AUC(0-inf), (0.30 ±0.05) and (0.30 ±0.06) mg·L-1 at Cmax, (6.6 ±2.5) and (9.3 ±7.9) h the peak time (Tpeak), respectively.There were no significant differences between the two formulations. F was 96.4 ±21.1 calculated by AUC(0 -t) and 96.4 ± 21.1 by AUC(0-inf). CONCLUSION: Glimepiride tables and capsules are of bioequivalence.

Key words: glimepiride, HPLC, bioequivalence

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