/ CompletedNot Applicable 琥珀酸索利那新口服混悬液在健康参与者中空腹与餐后条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验
[Translation] An open-label, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of solifenacin succinate oral suspension in healthy participants under fasting and postprandial conditions.
研究空腹与餐后状态下单次口服受试制剂(琥珀酸索利那新口服混悬液,规格 150mL:0.15g,北京远方通达医药技术有限公司持证)和参比制剂(琥珀酸索利那新口服混悬液,规格1mg/mL,商品名:VESICARE,Astellas Pharma Europe B.V.持证)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of the test formulation (solifenacin succinate oral suspension, 150 mL: 0.15 g, certified by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.) and the reference formulation (solifenacin succinate oral suspension, 1 mg/mL, trade name: VESICARE, certified by Astellas Pharma Europe B.V.) in healthy participants under fasting and postprandial conditions. The bioequivalence of the test and reference formulations was compared, and the safety of the drugs in healthy participants was also investigated.
/ CompletedNot Applicable 阿托伐他汀钙口服混悬液在健康参与者中空腹条件下开放、随机、单次给药、两制剂、两序列、四周期完全重复交叉设计生物等效性试验
[Translation] An open-label, randomized, single-dose, two-formulation, two-sequence, four-period fully replicate crossover bioequivalence study of atorvastatin calcium oral suspension in healthy participants under fasting conditions.
研究空腹状态下单次口服受试制剂(阿托伐他汀钙口服混悬液,规格150ml:0.6g,北京远方通达医药技术有限公司持证)与参比制剂(阿托伐他汀钙口服混悬液,规格20mg/5mL,商品名Atorvaliq®,CMP DEVELOPMENT LLC持证)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of the test formulation (atorvastatin calcium oral suspension, 150ml:0.6g, certified by Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.) and the reference formulation (atorvastatin calcium oral suspension, 20mg/5mL, trade name Atorvaliq®, certified by CMP DEVELOPMENT LLC) in healthy participants under fasting conditions. The bioequivalence of the test and reference formulations was compared, and the safety of the drugs in healthy participants was also investigated.
/ CompletedNot Applicable 硫普罗宁片在健康参与者中餐后条件下开放、随机、单次给药、两制剂、两序列、两周期交叉设计生物等效性试验
[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of tiopronin tablets in healthy participants after a mid-day meal
研究餐后状态下单次口服受试制剂(硫普罗宁片,规格0.1g,华益药业科技(安徽)有限公司生产)与参比制剂(硫普罗宁片,规格100mg,商品名:Thiola,ヴィアトリス製薬株式会社生产)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性。
[Translation] To study the pharmacokinetic characteristics of the test preparation (Tiopronin tablets, specification 0.1g, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (Tiopronin tablets, specification 100mg, trade name: Thiola, produced by Viatris Pharmaceutical Co., Ltd.) after a single oral administration in healthy participants in the postprandial state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drugs in healthy participants.
100 Clinical Results associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
100 Deals associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.