2002•华中科技大学学报：医学英德文版Requires access
Bioequiwalence of clavulanate Potassium and Amoxicillin（1：7）dispersible tablets in healthy volunteers
胡国新, 代宗顺, 龙利红, 韩颖, 侯淑贤, 吴立
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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.