[Translation] Mesalazine Extended-Release Granules in a Single-Center, Randomized, Open-Label, Two-Formulation, Single-Dose, Four-Period, Fully Repeated Crossover, Fasting/Postprandial Bioequivalence Study in Healthy Participants
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后条件下口服受试制剂美沙拉秦缓释颗粒(规格:1g,持证商:合肥英太制药有限公司)与参比制剂美沙拉秦缓释颗粒(规格:1g,按美沙拉秦(C7H7NO3)计),持证商:FerringS.A.S,商品名:Pentasa®)后在健康试验参与者体内的药代动力学行为,评价两种制剂的生物等效性。 次要目的:观察受试制剂和参比制剂在健康试验参与者中的安全性;评价受试制剂和参比制剂的适口性。
[Translation] Primary objective: To evaluate the bioequivalence of the test formulation mesalazine extended-release granules (1g, manufacturer: Hefei Yingtai Pharmaceutical Co., Ltd.) and the reference formulation mesalazine extended-release granules (1g, calculated as mesalazine (C7H7NO3)), manufacturer: Ferring S.A.S., trade name: Pentasa®), in healthy participants after oral administration under fasting and postprandial conditions, using pharmacokinetic parameters as the primary endpoint. Secondary objectives: To observe the safety of the test and reference formulations in healthy participants; to evaluate the palatability of the test and reference formulations.