格列齐特片在健康人体内的相对生物利用度

目的 研究格列齐特片在健康人体内的相对生物利用度, 评价两种格列齐特片剂的生物等效性。方法 10 名健康受试者口服格列齐特受试片和参比片后, 采用高效液相色谱法测定血药浓度, SCIENTIS 程序拟合药代动力学参数, t检验比较组间差异, 双单侧检验评价生物等效性。结果 格列齐特血药浓度—时间曲线符合单室开放模型, 受试片和参比片的达峰时间T_max分别为(4.272±0.631)h 和(4.031±0.574)h, 达峰浓度C_max为(7.497±0.935)μg·ml^-1 和(7.408±1.171)μg·ml^-1, 曲线下面积AUC 为(104.986±27.523)μg·h·ml^-1 和(108.232±22.437)μg·h·ml^-1, 两组间均无显著性差异(P>0.05)。结论 格列齐特受试片的相对生物利用度为96.679%, 格列齐特受试片与参比片具有生物等效性。

Relative bioavailability and bioequivalence evaluation of gliclazide tablets

Aim To compare relative bioavailability and bioequivalence of gliclazide tablets. Methods Ten healthy male volunteers in two groups were given orally gliclazide tested and reference tablets (160 mg)in randomized crossover study.The serum concentration of gliclazide was assayed by HPLC and the bioequivelence of two formulations was evaluated by analysis of two onesided tests.Results Serum concentration-time curves of gliclazide fitted to an one-compartment open model.T_max were (4.272±0.631)h and (4.031±0.574)h, C_max were (7.497±0.935)μg·ml^-1 and (7.408±1.171)μg·ml^-1 and AUC were (104.986±27.523)μg·h·ml^-1 and (108.232±22.437) μg·h·ml^-1 for tested and reference tablets, respectively.The relative bioavailability of gliclazide tested tablet was 96.679%. Conclusion The tested and reference tablets of gliclazide are of bioequivalence.