健康受试者空腹和餐后状态下单剂量口服贝前列素钠片(40μg)的随机、开放、两制剂、两序列、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, two-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of a single oral dose of beraprost sodium tablets (40 μg) in healthy subjects in the fasting and fed state
主要目的:比较空腹和餐后单次给药条件下,北京康晟百春生物科技有限公司持证的贝前列素钠片(规格:40μg,受试制剂)与武田テバファーマ株式会社(Teva Pharma Japan Inc)持证的贝前列素钠片(规格:40μg,参比制剂)在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数,评价两者是否生物等效。
次要目的:通过观察健康受试者单次口服受试制剂和参比制剂后的安全性指标,评价贝前列素钠片的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and rate of beraprost sodium tablets (specification: 40μg, test preparation) certified by Beijing Kangsheng Baichun Biotechnology Co., Ltd. and beraprost sodium tablets (specification: 40μg, reference preparation) certified by Takeda Teva Pharma Japan Inc. (Teva Pharma Japan Inc) in healthy subjects under the conditions of single administration on an empty stomach and after a meal. To evaluate whether the two are bioequivalent by the main pharmacokinetic parameters.
Secondary objective: To evaluate the safety of beraprost sodium tablets by observing the safety indicators of healthy subjects after a single oral administration of the test preparation and the reference preparation.
[Translation] Study on the bioequivalence of faropenem sodium granules in children
主要目的:采用单剂量、随机、开放、双周期交叉、空腹及餐后口服给药设计,比较北京康晟百春生物科技有限公司持证的小儿法罗培南钠颗粒(规格:0.05 g,按C12H15NO5S计)与Maruho Co.,Ltd.(玛路弘株式会社)持证的小儿法罗培南钠颗粒(规格:0.05 g,按C12H15NO5S计)在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:评价小儿法罗培南钠颗粒(规格:0.05 g,按C12H15NO5S计)受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Primary objective: To compare the differences in absorption extent and absorption rate between the pediatric faropenem sodium granules (specification: 0.05 g, calculated as C12H15NO5S) certified by Beijing Kangsheng Baichun Biotechnology Co., Ltd. and the pediatric faropenem sodium granules (specification: 0.05 g, calculated as C12H15NO5S) certified by Maruho Co., Ltd. in healthy Chinese population by using a single-dose, randomized, open, two-period crossover, fasting and postprandial oral administration design, and to evaluate bioequivalence.
Secondary objective: To evaluate the safety of the test and reference preparations of the pediatric faropenem sodium granules (specification: 0.05 g, calculated as C12H15NO5S) in healthy subjects.
100 Clinical Results associated with Beijing Kangsheng Baichun Biotechnology Co., Ltd.
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100 Deals associated with Beijing Kangsheng Baichun Biotechnology Co., Ltd.
100 Translational Medicine associated with Beijing Kangsheng Baichun Biotechnology Co., Ltd.