摘要
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Tmax 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。
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. Tmax were (4.272±0.631) h and (4.031±0.574) h, Cmax 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.
出处
《中国临床药理学与治疗学》
CAS
CSCD
1999年第2期112-114,共3页
Chinese Journal of Clinical Pharmacology and Therapeutics
