[Translation] Bioequivalence study of ursodeoxycholic acid capsules in healthy subjects under single-center, open, balanced, randomized, single-dose, double-cycle, double-crossover fasting and postprandial states
主要目的
比较空腹及餐后给药条件下,深圳市资福药业有限公司生产的熊去氧胆酸胶囊(250mg/粒)与Dr. Falk Pharma GmbH持证的熊去氧胆酸胶囊(250mg/粒,商品名:Ursofalk®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹及餐后给药条件下,深圳市资福药业有限公司生产的熊去氧胆酸胶囊(250mg/粒)与参比制剂Ursofalk®(250mg/粒)的安全性。
[Translation] main purpose
Comparing the ursodeoxycholic acid capsules (250mg/capsule) produced by Shenzhen Zifu Pharmaceutical Co., Ltd. and the ursodeoxycholic acid capsules (250mg/capsule) licensed by Dr. Falk Pharma GmbH under the conditions of fasting and postprandial administration. , trade name: Ursofalk®) differences in the extent and rate of absorption in healthy adults to evaluate its bioequivalence.
secondary purpose
To evaluate the safety of ursodeoxycholic acid capsules (250mg/capsule) produced by Shenzhen Zifu Pharmaceutical Co., Ltd. and the reference preparation Ursofalk® (250mg/capsule) under the conditions of fasting and postprandial administration.