[Translation] Randomized, open-label, two-dose, two-cycle, two-sequence, crossover healthy subjects postprandial single-dose human bioequivalence trial of tadalafil tablets
以健康志愿者为试验对象,采用随机、开放、两制剂、两周期、两序列、交叉试验设计,考察健康受试者餐后单次口服受试制剂与参比制剂后他达拉非的体内经时过程,估算其相关药代动力学参数及相对生物利用度,评价其餐后状态下的生物等效性。为受试制剂的安全、合理使用提供依据。
[Translation] Taking healthy volunteers as test objects, a randomized, open, two-preparation, two-cycle, two-sequence, crossover trial design was adopted to investigate the in vivo effects of tadalafil after a single oral dose of test preparation and reference preparation in healthy subjects after meals. Over time, the relevant pharmacokinetic parameters and relative bioavailability were estimated, and the bioequivalence in the postprandial state was evaluated. Provide a basis for the safe and rational use of the tested preparations.