[Translation] Study on the bioequivalence of ursodeoxycholic acid capsules in healthy volunteers
采用随机、开放、两周期交叉、单次口服试验设计比较空腹和餐后给药条件下,葵花药业集团(唐山)生物制药有限公司提供的熊去氧胆酸胶囊(规格:250 mg)与Dr. Falk Pharma GmbH持证Losan Pharma GmbH生产的熊去氧胆酸胶囊(商品名:优思弗®/Ursofalk®;规格:250 mg)在中国健康人群吸收程度和吸收速度的差异,并评价葵花药业集团(唐山)生物制药有限公司提供的熊去氧胆酸胶囊(规格:250 mg)的安全性。
[Translation] A randomized, open, two-period crossover, single oral trial design was used to compare the differences in absorption extent and absorption rate of ursodeoxycholic acid capsules (specification: 250 mg) provided by Sunflower Pharmaceutical Group (Tangshan) Biopharmaceutical Co., Ltd. and ursodeoxycholic acid capsules (trade name: Ursofalk®/Ursofalk®; specification: 250 mg) produced by Losan Pharma GmbH (licensed by Dr. Falk Pharma GmbH) in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of ursodeoxycholic acid capsules (specification: 250 mg) provided by Sunflower Pharmaceutical Group (Tangshan) Biopharmaceutical Co., Ltd.
100 Clinical Results associated with Sunflower Pharmaceutical Group (Tangshan) Bio-Pharm Co., Ltd.
0 Patents (Medical) associated with Sunflower Pharmaceutical Group (Tangshan) Bio-Pharm Co., Ltd.
100 Deals associated with Sunflower Pharmaceutical Group (Tangshan) Bio-Pharm Co., Ltd.
100 Translational Medicine associated with Sunflower Pharmaceutical Group (Tangshan) Bio-Pharm Co., Ltd.