[Translation] Randomized, open-label, three-period crossover, single-dose evaluation of relative bioavailability and bioequivalence of levoornidazole dispersible tablets
本试验旨在研究空腹及餐后单次口服湖南华纳大药厂股份有限公司研制、生产的受试制剂(左奥硝唑分散片、左奥硝唑胶囊)的药代动力学特征,并以湖南华纳大药厂股份有限公司生产的左奥硝唑片作为参比制剂,比较三种制剂的药动学参数,评价两种受试制剂相对于参比制剂的相对生物利用度及人体生物等效性。
[Translation] The purpose of this experiment is to study the pharmacokinetic characteristics of the tested preparations (Levo-Ornidazole Dispersible Tablets, Levo-Ornidazole Capsules) developed and produced by Hunan Huana Pharmaceutical Co., Ltd. after a single oral administration on an empty stomach and after meals. The levoornidazole tablets produced by Hunan Huana Pharmaceutical Co., Ltd. were used as the reference preparation to compare the pharmacokinetic parameters of the three preparations, and to evaluate the relative bioavailability of the two test preparations relative to the reference preparation and the biological properties of the human body. effectiveness.