佐匹克隆片在健康志愿者的生物等效性研究

目的：评价两种佐匹克隆片的生物等效性。方法：采用两制剂双周期交叉试验的方法，24名男性健康受试志愿者分别口服佐匹克隆分散片试验药或对照药7．5mg，采用高效液相荧光法测定佐匹克隆的浓度，用3p97软件进行生物等效性评价。结果：试验药与对照药的主要药动学参数：t1／2分别为（5．40±1．72），（5．62±1．95）h；Cmax分别为（72．68±11．59），（77．98±15．06）ng·ml^-1；tmax分别为（1．45±0．64），（1．33±0．34）h；AUC0-24h分别为（322．09±40．20），（336．70±39．65）μg·h^-1·L^-1.结论：两种佐匹克隆片生物等效。

Bioequivanlence of Zopiclone Tablet in Healthy Volunteers

Objective： To evaluate the bioequivalence between domestic and imported zopiclone tablets. Method： Twenty-four healthy male volunteers were treated with a dose of 7.5 mg zopiclone tablet by a randomized crossover design. Plasma concentrations of zopiclone were determined by HPLC and the bioequivalence between two formulations were evaluated by 3P97 program. Result： The pharmacokinetic parameters of domestic and imported zopiclone tablets were expressed as follow： t1/2 were （5.40 ± 1.72）h and （5.62±1.95） h;Cmax were （72.68 ±11.59） and （77.98 ±15.06） ng.ml^-1,tmax were （1.45 ±0.64） h and （1.33 ±0.34） h, AUC0-24h were （322. 09 ±40. 20） and （336. 70 ±39. 65） μg·h^-1 · L^-1 ,respectively. Conclusion： Domestic and imported zopiclone tablets are bioequivalent.