国产格列美脲片剂在健康男性志愿者的生物等效性评价

目的 以单剂量试验判定格列美脲片剂与参比胶囊剂的生物等效性。 方法 20 名健康男性志愿者随机分成两组, 采用3 mg 单剂量(口服) 交叉试验设计, 以高效液相法测定血药浓度, 以3p97 药代动力学程序求算, 等效性分析用双单侧t 检验。 结果 格列美脲片剂和参比胶囊剂的AUC_(0-t) 分别为(1.23 ±0.19) 和(1.31 ±0.22) mg·h·L^-1, AUC_(0-inf)分别为(1.32 ±0.20) 和(1.45 ±0.24) mg·h·L^-1,C_max分别为(0.30 ±0.05) 和(0.30 ±0.06) mg·L^-1,T_peak分别为(2.43 ±0.29) 和(2.55 ±0.46) h, T_1/2Ke分别为(6.9 ±2.5) 和(9.3 ±7.9) h。F_AUC(0-t) =96.4 ±21.1, F_AUC(0-inf) =93.7 ±20.7。 结论 格列美脲片剂和参比胶囊剂生物等效。

Evaluation of bioequivalence of domestic glimepiride tablet in Chinese healthy male volunteers

AIM: To compare the bioequivalence of glimepiride tables and capsules with a single dose. METHODS: Twenty Chinese healthy male volunteers were enrolled in a randomized crossover study with a single oral dose 3 mg of two formulations respectively.The blood drug concentration in serum was measured by HPLC, and the pharmacokinetic parameters were calculated by 3p97 software and compared by two one-side ttest. RESULTS: The parameters of the tables and the capsules were (1.23 ± 0.19) and (1.31 ± 0.22) mg·h·L^-1at AUC_{(0 -t)}, (1.32 ±0.20) and (1.45 ± 0.24) mg·h·L^-1 at AUC_(0-inf), (0.30 ±0.05) and (0.30 ±0.06) mg·L^-1 at C_max, (6.6 ±2.5) and (9.3 ±7.9) h the peak time (T_peak), respectively.There were no significant differences between the two formulations. F was 96.4 ±21.1 calculated by AUC_{(0 -t)} and 96.4 ± 21.1 by AUC_(0-inf). CONCLUSION: Glimepiride tables and capsules are of bioequivalence.