2010•Zhongguo yaofangRequires access
Pharmacokinetics and Bioequivalence of 2 Kinds of Amoxicillin Dispersible Tablets in Healthy Volunteers
Yuzhen Li, Huan Cai
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Abstract
OBJECTIVE:To study the pharmacokinetics and bioequivalence of 2 kinds of Amoxicillin dispersible tablets in healthy volunteers. METHODS: In randomized cross-over controlled study, 20 healthy male volunteers received a single oral dose of test amoxicillin tablets 500 mg and reference amoxicillin tablets 500 mg. Plasma concentration of amoxicillin was detected by HPLC and pharmacokinetic parameters and bioavailability of 2 kinds of amoxicillin dispersible tablets were calculated by DAS software. RESULTS: The main pharmacokinetic parameters of test tablets vs. reference tablets were as follows:Cmax(11.11±3.63) μg·mL-1 vs. (9.93±3.39)μg·mL-1;tmax(1.14±0.42) h vs. (1.34±0.47) h; t1/2(1.08±0.52) h vs. (1.07±0.66) h; AUC0～6(24.49±6.22)μg·h·mL-1 vs. (22.44±5.98)μg·h·mL-1; AUC0～∞(25.21±6.44)μg·h·mL-1 vs. (23.40±6.25)μg·h·mL-1 respectively. According to AUC0～6, the relative bioavailability of test tablets was 110.3%. CONCLUSION: Two kinds of amoxicillin tablets are bioequivalent and interchangeable.