/ CompletedNot Applicable [Translation] Study on the bioequivalence of ursodeoxycholic acid tablets in healthy volunteers
主要目的:考察在空腹及餐后条件下,健康受试者口服熊去氧胆酸片受试制剂及参比制剂,比较两制剂在人体内的血药浓度及药动学参数,评价两者在健康受试者体内是否具有生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Main purpose: To investigate the oral administration of the test preparation and reference preparation of ursodeoxycholic acid tablets to healthy subjects under fasting and postprandial conditions, to compare the blood drug concentration and pharmacokinetic parameters of the two preparations in humans, and to evaluate whether the two preparations are bioequivalent in healthy subjects.
Secondary purpose: To observe the safety of the test preparation and reference preparation in healthy subjects.
100 Clinical Results associated with Wuhan Puyuan Pharmaceutical Co., Ltd.
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