Bioequivalence of amoxicillin-clavulanate potassium (14 : 1) granules

Objective: To determine the bioequivalence of amoxicillin-clavulanate potassium (14 : 1) granules in healthy volunteers. Methods: A randomized cross-over (5 days in distance) study on the bioequivalence of amoxicillin-clavulanic acid granules compared with amoxicillin-clavulanic acid tablet were done in 18 healthy male volunteers. One granules tablet (each tablet contains amoxicillin 600 mg + clavulanic acid 42. 9 mg) or one common form tablet (each tablet contains the same amount of amoxi cillin and clavulanic acid ) were given to every volunteer in each experiment. Serum samples at different time were taken and drug concentration were measured by bioassay method. Results: The pharmacokinetic parameters of granule tablet and common form tablet were amoxicillin AUC0-8h (25. 5 ±4. 12) mg · h/L and (25.0±4.05) mg · h/L, Cmax(9. 95 ± 1. 45) mg/L and( 9. 48 ± 1. 66) mg/L, clavulanate potassium AUC0-8h(1. 38 ±0. 467) mg · h/L and (1. 46 ± 0. 508) mg · h/L, Cmax(0. 648 ± 0. 586 )mg/L and (0. 586 ± 0. 167) mg/L respectively. Conclusions: The two preparations of amoxicillin-clavulanate potassium are bioequivalent.