Bioequivalence of amoxycillin-clavulanic acid tablet and suspension

Objective: To study the bioequivalence of amox ycillin-clavulanic acid tablet and suspension in healthy volunteers. Methods: Twenty-one normal male volunteers were enrolled in a random ized crossover study. Each volunteer was given a single oral dose of amoxycillin -clavulanic acid tablet or suspension (test preparations) and reference prepara tion (tablet) for comparison. The plasma concentrations of amoxycillin and clavu lanic acid were determined by HPLC. Results: The pharmacok in etic parameters of test amoxycillin tablet,test suspension and reference tablet were:C max (20.56±3.34) mg/L, (22.53±3.86) mg/L and (19.53±2.91) m g/L respectively; median T max 2.00 (1.5, 4.0) h, 2.00 (1.5, 3.0) h and 2.00 (1.5, 5.0) h respectively; AUC 0-∞ (102.48±21.83) h·mg/L, (97.76 ±18.90) h·mg/L and (97.95±19.77) h·mg/L respectively. The pharmacokinetic pa rameters of clavulanic acid tablet, suspension and reference tablet were: C max (4.58±1.54) mg/L, (5.25± 1.20) mg/L and (4.63±1.33) mg/L respect ively; median T max 1.5 (1.0, 4.0) h, 1.0 (1.0, 4.0) h and 1.5 (1.0,4.0) h respectively;AUC 0-∞ (13.70±4.01) h·mg/L, (14.05±3.99) h·mg/L and (1 3.60±3.56) h·mg/L respectively. The relative bioavailability of amoxycillin or al tablet and suspension were (105.26±13.73)% and (101.20±16.59)% respectively . The relative bioavailability of clavulanic acid oral tablet and suspension wer e (100.71±11.62)% and (103.18±8.91)% respectively. Conclusions:Serum concentration- versus-time data fit one compartment model. Results show that test preparations and reference tablet are bioequivalent. [