Bioequivalence of clavulanate potassium and amoxicillin (1:7) dispersible tablets in healthy volunteers / 华中科技大学学报（医学）（英德文版）

ABSTRACT

To study the bioequivalence of Clavulanate Potassium and Amoxicillin (17) dispersible tablets, a randomized cross-over study was conducted in 18 healthy volunteers. A single oral dose of 1,000 mg Clavulanate Potassium and Amoxicillin (17) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main parameters of T were for Clavulanate Potassium and Amoxicillin, Cmax 2.46 +/- 1.11 micrograms/ml and 18.81 +/- 7.26 micrograms/ml, Tmax 1.12 +/- 0.23 h and 1.30 +/- 0.34 h, AUC(0-6 h) 5.18 +/- 2.24 micrograms.h/ml and 45.09 +/- 14.53 micrograms.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.