Bioequivalence Study of Amoxicillin and Clavulanate Disperse Tablets in Healthy Volunteers

OBJECTIVE: To study the bioequivalence of amoxicillin and clavulanate (7:1) disperse tablets tested to the reference. METHODS: Single oral dose (800: 114, mg) of amoxicillin and clavulanate (7:1) dispersive tablets tested and the reference were given to 23 healthy male volunteers in a randomized cross-over study. The plasma amoxicillin and clavulanic acid concentration of the volunteers were determined by column-switching HPLC. RESULTS: The concentration - time curves of amoxicillin and clavulanic acid conformed one-compartment modol. Amoxicillin of tested and the reference, AUC_(0-8) were 33.93±3.22 and 33.81±5.70 h·mg·L~(-1), C_(max) were 13.22±0.91 and 12.09±2.88 mg·L~(-1), t_(max) were 1.42±0.18 and 1.50±0.18 h, respectively. Clavulanic acid of tested and the reference, AUC_(0-6) were 5.01±0.77 and 5.51±0.18 h·mg·L~(-1), C_(max) were 2.39±0.31 and 2.72±0.29 mg L~(-1), t_(max) were 1.19±0.35 and 1.33±0.35 h, respectively. The relative bioavailability of tested to the reference were (103.4±30.5) % and (91.0±27.0) %, amoxicillin and clavulanic acid, respectively. The 90 % confidential interval of test in the reference lgAUC_(0-1) were 97.0 %-102.2 % and 84.1 %-102.6 %, lgC_(max) were 98.8 %- 118.1 % and 81.9 %-101.0 %, amoxicillin and clavulanic acid, respectively. There was no difference of t_(max) rank sum tests. CONCLUSION: The tested and the reference preparations were bioequivalent of amoxicillin and clavulanate.