[Translation] A randomized, open-label, two-dose, two-period, self-crossover, formal bioequivalence trial of oral rifampicin capsules in healthy subjects under fasting conditions
主要目的:观察健康受试者空腹状态下单剂量口服受试制剂利福平胶囊(0.15g)后血药浓度的经时过程,估算相应的药代动力学参数;并以利福平胶囊(0.15g,Sanofi-Aventis US LLC,商品名:RIFADIN)为参比制剂,进行生物等效性正式试验,为该药一致性评价申报和临床应用提供参考依据。
次要目的:观察受试者空腹状态下口服受试制剂和参比制剂的安全性。
[Translation] Main purpose: To observe the time course of blood drug concentration after a single oral dose of the test preparation rifampicin capsule (0.15g) in healthy subjects in the fasting state, and to estimate the corresponding pharmacokinetic parameters; and to conduct a formal bioequivalence test using rifampicin capsule (0.15g, Sanofi-Aventis US LLC, trade name: RIFADIN) as the reference preparation, to provide a reference for the consistency evaluation application and clinical application of the drug.
Secondary purpose: To observe the safety of the test preparation and the reference preparation when the subjects take them orally in the fasting state.