Study on the bioequivalence of domestic loratadine in healthy volunteers

LIU Yu; et al

doi:10.13406/j.cnki.cyxb.2003.05.019

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Study on the bioequivalence of domestic loratadine in healthy volunteers

更新时间：2024-01-17

- Study on the bioequivalence of domestic loratadine in healthy volunteers
- Journal of Chongqing Medical University Issue 5, Pages: 614-616(2003)
- 作者机构：
  
  1. 重庆医科大学临床学院药剂科
  2. 重庆医科大学临床学院药剂科,重庆,400016
- 作者简介：
- 基金信息：
- DOI：10.13406/j.cnki.cyxb.2003.05.019
  CLC： R969
- Published：2003，
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[1]刘宇,毛郴,何海霞,周远大.国产氯雷他定片人体生物等效性研究[J].重庆医科大学学报,2003(05):614-616+652.

LIU Yu, et al. Study on the bioequivalence of domestic loratadine in healthy volunteers. [J]. Journal of Chongqing Medical University (5):614-616(2003)
[1]刘宇,毛郴,何海霞,周远大.国产氯雷他定片人体生物等效性研究[J].重庆医科大学学报,2003(05):614-616+652. DOI： 10.13406/j.cnki.cyxb.2003.05.019.

LIU Yu, et al. Study on the bioequivalence of domestic loratadine in healthy volunteers. [J]. Journal of Chongqing Medical University (5):614-616(2003) DOI： 10.13406/j.cnki.cyxb.2003.05.019.

摘要

目的 :2 0名健康男性受试者随机交叉口服 2 0mg西南合成制药总厂研制的氯雷他定片（LORAX）与上海先灵葆雅制药有限公司生产的氯雷他定片（开瑞坦

LORAS）进行药代动力学和生物等效性研究。方法 :采用高效液相色谱法测定血中氯雷他定浓度。结果 :经 3p97程序拟合和计算

LORAX和LORAS的Cmax为 8.5 9± 6 .70和 9.5 9± 8.2 2ng/ml;Tmax为 1.0 8±0 .4 1和 1.2 1± 0 .2 8h ;AUC0 -t为 2 7.2 9± 2 4 .5 4和 2 7.12± 2 0 .6 4ng·h/ml。结论 :经方差分析和双单侧检验

结果表明两者具有生物等效性

LORAX片的相对生物利用度为 10 0 .6 3± 14 .2 7%。

Abstract

Objective:To study the bioequivalence and pharmacokinetics of two kinds of loratadine tablets in 20 healthy volunteers.Methods:An oral dose of 20mg of test or reference loratadine tablets was given according to a randomized 2-way cross-over design

blood samples were withdrawn up to 12 hours past administration

and plasma concentration of loratadine was determined by HPLC method.Results:The peak plasma levels (C max ) of loratadine test drug and reference drug were 8.59±6.70 or 9.59±8.22ng/ml respectively. The peak time (T max ) were 1.08±0.41 or 1.21±0.28h respectively

and AUC 0-t were 27.29±25.54 or 27.12±20.64ng·h/ml respectively.Conclusion:The result of statistic analysis and tow one-sided test suggest that the domestic loratadine talbet is bioequivalent to the imported tablet.The relative bioavailability of domestic loratadine tablets is 100.63%±14.27%.

关键词

氯雷他定生物等效性高效液相色谱法

Keywords

LoratadinebioequivalenceHPLC

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