Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers

LI Cen; et al

doi:10.13406/j.cnki.cyxb.2003.03.015

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Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers

更新时间：2024-01-17

- Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers
- Journal of Chongqing Medical University Issue 3, Pages: 307-309(2003)
- 作者机构：
  
  1. 重庆医科大学临床学院药剂科
  2. 重庆市三峡中心医院药剂科
  3. 重庆医科大学临床药理研究室,重庆,404001
- 作者简介：
- 基金信息：
- DOI：10.13406/j.cnki.cyxb.2003.03.015
  CLC： R969
- Published：2003，
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[1]李岑,张斌,郑永,何海霞,周远大,陈锋杰.格列齐特胶囊人体药代动力学及相对生物利用度研究[J].重庆医科大学学报,2003(03):307-309.

LI Cen, et al. Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers. [J]. Journal of Chongqing Medical University (3):307-309(2003)
[1]李岑,张斌,郑永,何海霞,周远大,陈锋杰.格列齐特胶囊人体药代动力学及相对生物利用度研究[J].重庆医科大学学报,2003(03):307-309. DOI： 10.13406/j.cnki.cyxb.2003.03.015.

LI Cen, et al. Pharmacokinetics and relative bioavailability of Gliclazide capsules in healthy volunteers. [J]. Journal of Chongqing Medical University (3):307-309(2003) DOI： 10.13406/j.cnki.cyxb.2003.03.015.

摘要

目的 :对重庆力司特制药有限公司研制的格列齐特胶囊（LSGL）与陕西丰禾制药有限公司生产的格列齐特胶囊（FHGL）进行人体相对生物等效性研究。方法 :2 0名健康男性志愿受试者随机交叉单剂量口服 80mgLSGL或FHGL

用高效液相色谱法测定血浆中格列齐特（GL）浓度

经 3P97生物利用度和生物等效性计算程序处理拟合。结果 :LSGL或FHGL体内药时曲线符合一室模型

LSGL或FHGL的Cmax分别为 4 .5 0± 0 .83和 4 .5 4± 1.0 4 μg/ml;Tmax分别为 4 .0 5± 0 .89和 4 .0 5± 0 .76h ;AUC（0～T）分别为 80 .30± 2 6 .87

82 .5 9± 2 6 .2 0 μg·h·ml-1;相对生物利用度为 97.2 3+12 .5 8%。结论 :经方差分析和单双侧t检验

表明LSGL或FHGL具有生物等效性。

Abstract

Objective:The relative bioavailability and pharmacokinetics of Chongqing Lisi(LSGL) or Shanxi Fenghe Gliclazide capsules(FHGL) were studied in 20 healthy male volunteers. Methods:A single dose of 50mg of LSGL or FHGL was administered by randvmized crossover way in 20 volunteers and the plasma concentrations of Gliclazide(GL) were determined by HPLC.The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioequivalency was evaluated.Results:The concentration-time curves of two proparations fitted to one-compartment model.The peak plasma levels (C max ) of LSGL and FHGL were 4.50±0.83 and 4.54±l.04μg/ml

respectively;the peak time (T max ) was 4.05+0.89 and 4.05±0.76h

respectively;and AUC (0～T) were 80.30±26.87

82.59±26.20μg·h·ml -1

respectively.The relative bioavailability of LSGL was 97.23±12.58%.Conclusion:The result of two one-side tests suggest that the LSGL is bioequivalent to the FHGL.

关键词

格列齐特生物等效性高效液相色谱法

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