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Bioequiwalence of clavulanate Potassium and Amoxicillin(1:7) dispersible tablets in healthy volunteers
引用本文:胡国新,代宗顺,龙利红,韩颖,侯淑贤,吴立. Bioequiwalence of clavulanate Potassium and Amoxicillin(1:7) dispersible tablets in healthy volunteers[J]. 华中科技大学学报(医学英德文版), 2002, 22(3)
作者姓名:胡国新  代宗顺  龙利红  韩颖  侯淑贤  吴立
作者单位:HU Guoxin,DAI Zongshun,LONG Lihon g,HAN Ying,Hou Shuxian,WU Li 2 1 Department of Pharmacology,Wenzhou Medical College,Wenzhou 325000 2 Department of Pharmacology,Tongji Medical College of Huazhong University of Science and Techn
摘    要:Clavulanate Potassium( CL S) and Amoxicillin( AMC) ( 1 :7) dispersible tablets,twice daily,isindicated for short term treatment of bacterial in-fections at several sites when amoxicillin resistantβ— lactamase producing strainsare suspected as thecause.Resistance to many antibiotics is caused bybacterial enzymes which destroy the antibiotic be-fore it can act on the pathogen.The ClavulanatePotassium in the compound can circumventthis de-fense mechanism by blocking theβ- lactamase en-zyme…


Bioequiwalence of clavulanate Potassium and Amoxicillin(1:7) dispersible tablets in healthy volunteers
HU Guoxin,DAI Zongshun,LONG Lihon g,HAN Ying,Hou Shuxian,WU Li. Bioequiwalence of clavulanate Potassium and Amoxicillin(1:7) dispersible tablets in healthy volunteers[J]. Journal of Huazhong University of Science and Technology. Medical sciences, 2002, 22(3)
Authors:HU Guoxin  DAI Zongshun  LONG Lihon g  HAN Ying  Hou Shuxian  WU Li
Affiliation:1. Department of Pharmacology, Wenzhou Medical College, Wenzhou 325000
2. Department of Pharmacology, Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430030
Abstract:Summary: To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1: 7) dispersible tablets, a randomized cross - over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main paramaters of T were: for Clavu lanate Potassium and Amoxicillin, Cmax: 2. 46±1.11 μg/ml and 18. 81±7. 26 μg/ml, Tmax 1. 12±0. 23h and 1. 30±0. 34h, AUC(0- 6h): 5. 18±2.24 μg * h/ml and 45. 09±14. 53 μg * h/ml, t1/2:1.43±0. 44 h and 1. 09±0.22 h. , respectively. The relative bioavailability of T to R were 96. 5±19. 2 % and 98. 4±26. 1 % , respectively. Statistical analysis showed that the two formulations were bioequivalent.
Keywords:Clavulanate Potassium  Amoxicillin  pharmacoki netics  bioavailability
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