[Translation] A single-center, randomized, open-label, single-dose, three-period, partially repeated crossover, fasting and fed human bioequivalence study of tauroursodeoxycholic acid capsules in healthy study participants
主要研究目的:
以湖北知化医药科技有限公司的牛磺熊去氧胆酸胶囊(规格:250mg)为受试制剂,以Bruschettini S.r.l.(意大利贝斯迪大药厂)持证的牛磺熊去氧胆酸胶囊(规格:250mg,商品名:滔罗特®/TAUROLITE®)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。 次要研究目的:
观察受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] Main research purpose:
Tauroursodeoxycholic acid capsules (specification: 250mg) of Hubei Zhihua Pharmaceutical Technology Co., Ltd. were used as the test preparation, and tauroursodeoxycholic acid capsules (specification: 250mg, trade name: TAUROLITE®) certified by Bruschettini S.r.l. (Italy Besti Pharmaceutical Factory) were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated. Secondary research purpose:
Observe the safety of the test preparation and the reference preparation in healthy research participants.