[Translation] A single-center, open, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of ursodeoxycholic acid capsules in healthy subjects under fasting and fed conditions
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
To compare the differences in the extent and rate of absorption of ursodeoxycholic acid capsules (250 mg/capsule) produced by Shenzhen Zifu Pharmaceutical Co., Ltd. and ursodeoxycholic acid capsules (250 mg/capsule, trade name: Ursofalk®) certified by Dr. Falk Pharma GmbH in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of ursodeoxycholic acid capsules (250 mg/capsule) produced by Shenzhen Zifu Pharmaceutical Co., Ltd. and the reference preparation Ursofalk® (250 mg/capsule) under fasting and postprandial administration conditions.