/ CompletedNot Applicable 阿哌沙班片在中国健康受试者中的单次给药、随机、开放、两制剂、两周期、空腹和餐后条件下的生物等效性试验
[Translation] A single-dose, randomized, open-label, two-dose, two-period, fasting and fed bioequivalence study of apixaban tablets in healthy Chinese subjects
本研究以河北凯威恒诚制药有限公司研制的阿哌沙班片(规格:2.5mg)为受试制剂 , 以BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCHINSTITUTE持证的阿哌沙班片(商品名:Eliquis®;规格:2.5mg)为参比制剂,评估受试制剂和参比制剂在空腹和餐后条件下的生物等效性。
[Translation] In this study, the apixaban tablets (specification: 2.5 mg) developed by Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd. were used as the test preparation, and the apixaban tablets (trade name: Eliquis®; specification: 2.5 mg) certified by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCHINSTITUTE were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting and fed conditions.
/ Not yet recruitingPhase 2 托吡司特片治疗痛风伴高尿酸血症的多中心、随机、双盲、阳性药物平行对照的II期研究
[Translation] A multicenter, randomized, double-blind, positive drug parallel controlled phase II study of topiramate tablets in the treatment of gout with hyperuricemia
主要目的:评估托吡司特片治疗痛风伴高尿酸血症的剂量-效应关系。
次要目的:与别嘌醇片比较,评估托吡司特片治疗痛风伴高尿酸血症的有效性和安全性。
[Translation] Primary objective: To evaluate the dose-effect relationship of topiramate tablets in the treatment of gout with hyperuricemia.
Secondary objective: To evaluate the efficacy and safety of topiramate tablets in the treatment of gout with hyperuricemia compared with allopurinol tablets.
/ Not yet recruitingPhase 3 一项评价托吡司特片治疗痛风伴高尿酸血症的多中心、随机、双盲、别嘌醇对照的III期临床研究
[Translation] A multicenter, randomized, double-blind, allopurinol-controlled phase III clinical trial evaluating topiramate tablets for the treatment of gout with hyperuricemia.
主要研究目的:与别嘌醇300mg相比,验证III期推荐剂量的托吡司特片治疗痛风伴高尿酸血症的有效性;
次要研究目的:与别嘌醇300mg相比,评价III期推荐剂量的托吡司特片治疗痛风伴高尿酸血症的安全性和耐受性。
[Translation] Primary study objective: To verify the efficacy of the Phase III recommended dose of topiramate tablets in treating gout with hyperuricemia compared to allopurinol 300 mg; Secondary study objective: To evaluate the safety and tolerability of the Phase III recommended dose of topiramate tablets in treating gout with hyperuricemia compared to allopurinol 300 mg.
100 Clinical Results associated with Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd.
100 Deals associated with Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hebei Kaiwei Hengcheng Pharmaceutical Co., Ltd.