Bioequivalence of domestic amoxycillin and clauvlanate dispersible tablets and imported augmentin syrup
Shi Ai-xin,Li Ke-xin,Liu Lei,Yi Qi, He Guang-weiandSun Chun-hua (Clinical Pharmacology Base of Beijing Hospital,Beijing 100730)
A single oral administration of 625mg domestic amoxycillin and clavulanate dispersible tablets and augmentin syrup were given to 20 healthy volunteers in an open randomized crossover study. Serum concentrations of amoxycillin and clavulanic acid were determined with RP-HPLC. The pharmacokinetic parameters for amoxycillin and clavulanate dispersible tablets and augmentin syrup were calculated as follows: AUC 0-t: (22.94±5.04)mg·h/L, (23.06±5.87)mg·h/L (amoxycillin), C max: (10.71±3.27)mg/L, (9.99±2.96)mg/L (amoxycillin), T max: (1.03±0.27)h, (0.95±0.26)h (amoxycillin), AUC 0-t: (5.23±1.50)mg·h/L, (5.42±1.49)mg·h/L (clavulanic acid), C max: (2.50±0.61)mg/L, (2.44± 0.69)mg/L (clavulanic acid), T max: (1.00±0.32)h, (1.05±0.33)h (clavulanic acid). The pharmacokinetic parameters showed that there were no significant difference between two products. The relative bioavailability of amoxycillin and clavulanate dispersible tablets were (101.2±15.8)% for amoxycillin and (97.3±13.7)% for clavulanic acid.