/ RecruitingNot Applicable [Translation] Study on the bioequivalence of Asartan potassium tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服北京民康百草医药科技有限公司持有、赤峰赛林泰药业有限公司生产的美阿沙坦钾片(80 mg)的药代动力学特征;以Takeda Pharma A/S持证、Takeda Ireland Ltd.生产的美阿沙坦钾片(易达比®,80 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of Asartan Potassium Tablets (80 mg), which is owned by Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. and produced by Chifeng Sailintai Pharmaceutical Co., Ltd.; using Asartan Potassium Tablets (Edabib®, 80 mg), which is licensed by Takeda Pharma A/S and produced by Takeda Ireland Ltd., as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable 小儿法罗培南钠颗粒在中国健康受试者中随机、开放、单剂量、两序列、两周期、双交叉、餐后给药条件下的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover, postprandial bioequivalence study of faropenem sodium granules in Chinese healthy subjects
主要研究目的
本试验以北京民康百草医药科技有限公司持证的小儿法罗培南钠颗粒,规格:0.05g(以C12H15NO5S计)为受试制剂,以Maruho Co.,Ltd.(玛路弘株式会社)持证的小儿法罗培南钠颗粒(商品名:菲若姆),规格:0.05g(以C12H15NO5S计)为参比制剂,评估受试制剂和参比制剂在餐后条件下的生物等效性。
次要研究目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main study purpose
This study uses the certified pediatric faropenem sodium granules of Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the test preparation, and the certified pediatric faropenem sodium granules (trade name: Feromu) of Maruho Co., Ltd., specification: 0.05g (calculated as C12H15NO5S) as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under postprandial conditions.
Secondary study purpose
Observe the safety of the test preparation and the reference preparation in healthy subjects.
/ Active, not recruitingNot Applicable 比拉斯汀片在中国健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、四周期、重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-dose, four-period, repeated crossover bioequivalence study of bilastine tablets in Chinese healthy subjects under fasting conditions
主要目的
本研究以北京民康百草医药科技有限公司委托赤峰赛林泰药业有限公司生产的比拉斯汀片(规格:20mg)为受试制剂,以原研单位Faes Farma, S.A.生产的比拉斯汀片(商品名:Bilaxten®,规格:20mg)为参比制剂,评估受试制剂和参比制剂在空腹条件下的生物等效性。
次要目的
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose
This study uses Bilastine Tablets (specification: 20 mg) produced by Chifeng Sailintai Pharmaceutical Co., Ltd. commissioned by Beijing Minkang Baicao Pharmaceutical Technology Co., Ltd. as the test preparation, and Bilastine Tablets (trade name: Bilaxten®, specification: 20 mg) produced by the original research unit Faes Farma, S.A. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting conditions.
Secondary purpose
Observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Beijing Minkang Baicao Medicine Technology Co.,Ltd.
0 Patents (Medical) associated with Beijing Minkang Baicao Medicine Technology Co.,Ltd.
100 Deals associated with Beijing Minkang Baicao Medicine Technology Co.,Ltd.
100 Translational Medicine associated with Beijing Minkang Baicao Medicine Technology Co.,Ltd.