Bioequiwalence of clavulanate Potassium and Amoxicillin (1∶7) dispersible tablets in healthy volunteers

Abstract

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 Clavulanate Potassium and Amoxicillin, C_max: 2.46±1.11 μg/ml and 18.81±7.26 μg/ml, T_max: 1.12±0.23h and 1.30±0.34h, ACU_(0–6h): 5.18±2.24 μg·h/ml and 45.09±14.53 μg·h/ml, t_1/2: 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 / pharmacokinetics / bioavailability

References

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