Relative Bioavailability and Bioequivalence of Zopiclone Tablets in Healthy Volunteers

Objective To investigate the pharmacokinetics and bioequivalence of zopiclone test and control tablets in health volunteers.Methods A single oral dose of 15 mg zopiclone test or control tablets were given to 20 healthy male volunteers in a randomized,two-way crossway study.HPLC-fluorescence detector was used to determine the concentration of zopiclone in plasma.By the DAS 2.1 pharmacokinetic software,the pharmacokinetic parameters of the two preparations were calculated and the bioequivalence of two tablets was evaluated.Results The main pharmacokinetic parameters of test and control preparations were as follows: t1/2 were(4.93±2.45) and(5.46±2.51) h;Cmax were(101.18±23.47) and(105.39±35.21) ng·mL-1;tmax were(1.60±1.16) and(1.64±1.35) h;AUC0-24 were(612.66±157.35) and(617.27±207.11) ng·h·mL-1;AUC0-∞ was(664.88±160.27) and(679.12±223.75) ng·h·mL-1;The relative bioavailability of test preparations(F0-t) was calculated to be(105.1±28.9)% according to AUC0-t.Conclusion The two kinds of domestic preparations are bioequivalent.