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/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of enteric-coated adenosylmethionine butanedisulfonate tablets in humans
在健康受试者体内,在空腹/餐后状态下,以ABBOTT LABORATORIES (M) SDN. BHD持证,ABBVIE S.R.L.生产的丁二磺酸腺苷蛋氨酸肠溶片(商品名:思美泰Transmetil;规格:0.5 g(以腺苷蛋氨酸计))为参比制剂,研究成都赛璟生物医药科技有限公司研制的丁二磺酸腺苷蛋氨酸肠溶片(受试制剂;规格:0.5 g(以腺苷蛋氨酸计))的吸收速度和吸收程度,评价受试制剂与参比制剂是否生物等效。观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] In healthy subjects, under fasting/postprandial conditions, the absorption rate and extent of enteric-coated adenosylmethionine butanedisulfonate tablets (trade name: Transmetil; specification: 0.5 g (in terms of adenosylmethionine)) produced by Chengdu Saijing Biopharmaceutical Technology Co., Ltd. (test preparation; specification: 0.5 g (in terms of adenosylmethionine)) were studied using ABBOTT LABORATORIES (M) SDN. BHD as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. The safety of the test preparation and the reference preparation in healthy Chinese subjects was observed.
评价 CG-7321 单药或联合治疗在晚期实体瘤受试者中安全性、耐受性、药代动力学特征及初步有效性的 I 期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of CG-7321 as a single agent or in combination therapy in subjects with advanced solid tumors
评价 CG-7321用于晚期实体瘤受试者的安全性、耐受性,确定CG-7321的最大耐受剂量(MTD)和临床II期推荐剂量(RP2D);评价 CG-7321用于晚期实体瘤受试者的药代动力学特征,初步评价CG-7321用于晚期实体瘤受试者的抗肿瘤活性。
[Translation] To evaluate the safety and tolerability of CG-7321 in subjects with advanced solid tumors, determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of CG-7321; to evaluate the pharmacokinetic characteristics of CG-7321 in subjects with advanced solid tumors, and preliminarily evaluate the anti-tumor activity of CG-7321 in subjects with advanced solid tumors.
/ CompletedNot Applicable [Translation] Study on bioequivalence of ursodeoxycholic acid oral suspension in healthy volunteers
采用单中心、随机、开放、两周期交叉、单剂量给药设计比较空腹和餐后给药条件下,成都赛璟生物医药科技有限公司委托江苏云阳集团药业有限公司生产的熊去氧胆酸口服混悬液(受试制剂T,规格:250mg: 5mL)与Dr. Falk Pharma GmbH持证生产的熊去氧胆酸口服混悬液(参比制剂R,商品名:Ursofalk®,规格:250 mg: 5 mL)在中国健康人群中吸收程度和吸收速度的差异,并评价两制剂的安全性。
[Translation] A single-center, randomized, open, two-period crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between ursodeoxycholic acid oral suspension (test preparation T, specification: 250 mg: 5 mL) produced by Jiangsu Yunyang Group Pharmaceutical Co., Ltd. on behalf of Chengdu Saijing Biotechnology Co., Ltd. and ursodeoxycholic acid oral suspension (reference preparation R, trade name: Ursofalk®, specification: 250 mg: 5 mL) produced by Dr. Falk Pharma GmbH under fasting and postprandial administration in healthy Chinese people, and to evaluate the safety of the two preparations.
100 Clinical Results associated with Chengdu Saijing Biomedical Technology Co., Ltd.
0 Patents (Medical) associated with Chengdu Saijing Biomedical Technology Co., Ltd.
100 Deals associated with Chengdu Saijing Biomedical Technology Co., Ltd.
100 Translational Medicine associated with Chengdu Saijing Biomedical Technology Co., Ltd.