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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7.5 mg,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:t_(1/2)分别为(5.40±1.72),(5.62±1.95)h;C_(max)分别为(72.68±11.59),(77.98±15.06)ng·ml~(-1);t_(max)分别为(1.45±0.64),(1.33±0.34)h;AUC_(0-24 h)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。
Objective: To evaluate the bioequivalence of two zopiclone tablets. Methods: Twenty-four male volunteers were orally administered with either Zacpirone dispersible tablets or 7.5 mg of the control drug, respectively. The concentration of zopiclone was determined by high performance liquid chromatography with 3p97 Software for bioequivalence assessment. Results: The main pharmacokinetic parameters of test drug and control drug were: t_ (1/2) = (5.40 ± 1.72), (5.62 ± 1.95) h; C_max were (72.68 ± 11.59), (77.98 ± 15.06) ng · ml ~ (-1) and t_ (max) were (1.45 ± 0.64) and (1.33 ± 0.34) h respectively; AUC 0-24 h were (322.09 ± 40.20) and (336.70 ± 39.65) μg · h ~ (-1) · L ~ (-1). Conclusion: Two zopiclone tablets are bioequivalent.