[Translation] Bioequivalence Test of Ursodeoxycholic Acid Tablets
评估受试制剂熊去氧胆酸片(规格:50 mg)与参比制剂熊去氧胆酸片(URSO®,规格:50 mg)在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究。
[Translation] To evaluate the single center of the test preparation ursodeoxycholic acid tablet (strength: 50 mg) and the reference preparation ursodeoxycholic acid tablet (URSO®, strength: 50 mg) in the fasting and fed state of healthy adult subjects. , open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study.
盐酸头孢卡品酯颗粒在中国健康受试者中随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验
[Translation] A randomized, open-label, fasting and postprandial, single-dose, two-cycle, double-crossover bioequivalence trial of cefcapine hydrochloride granules in healthy Chinese subjects
①主要目的:通过随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验以药代动力学参数为终点评价指标,评估受试制剂和参比制剂在空腹/餐后条件下给药时的相对生物利用度和生物等效性。
②次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] ① Main purpose: To evaluate the performance of the test preparation and the reference preparation in fasting/ Relative bioavailability and bioequivalence when administered under postprandial conditions.
②Secondary purpose: To observe the safety of test preparation and reference preparation in healthy subjects.
100 Clinical Results associated with Zhongshan Bailing Biotechnology Co., Ltd.
0 Patents (Medical) associated with Zhongshan Bailing Biotechnology Co., Ltd.
100 Deals associated with Zhongshan Bailing Biotechnology Co., Ltd.
100 Translational Medicine associated with Zhongshan Bailing Biotechnology Co., Ltd.