/ RecruitingNot Applicable 苯磺酸左氨氯地平片随机、开放、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A randomized, open-label, two-dose, crossover design formal bioequivalence trial of levamlodipine besylate tablets in Chinese healthy subjects
以石家庄市华新药业有限责任公司提供的苯磺酸左氨氯地平片为受试制剂;并以辉瑞制药有限公司的苯磺酸氨氯地平片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Levoamlodipine Besylate Tablets provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. were used as the test preparation, and amlodipine Besylate Tablets produced by Pfizer Pharmaceuticals Co., Ltd. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
/ Active, not recruitingNot Applicable 吡格列酮二甲双胍片在健康受试者中单剂量口服、随机、开放、两制剂、两周期生物等效性研究
[Translation] A single-dose oral, randomized, open-label, two-formulation, two-period bioequivalence study of pioglitazone and metformin tablets in healthy subjects
主要目的:
通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单剂量口服石家庄市华新药业有限责任公司研制和提供的吡格列酮二甲双胍片(规格:15mg/500mg/片)与武田テバ薬品株式会社生产的吡格列酮二甲双胍片(规格:15mg/500mg/片)的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:
评价单剂量口服吡格列酮二甲双胍片(规格:15mg/500mg/片)受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose:
Through a fasting/postprandial test study, the in vivo pharmacokinetic characteristics of a single oral dose of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) developed and provided by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) produced by Takeda Teba Pharmaceutical Co., Ltd. were investigated in healthy Chinese subjects under fasting/postprandial conditions, and the bioequivalence of the two preparations was evaluated.
Secondary purpose:
Evaluate the safety of a single oral dose of pioglitazone metformin tablets (specifications: 15mg/500mg/tablet) and the reference preparation in healthy Chinese subjects.
/ Active, not recruitingNot Applicable 沙库巴曲缬沙坦钠片在健康受试者中空腹/餐后单次口服给药、随机、开放、两制剂、四周期、完全重复交叉生物等效性试验
[Translation] A single oral fasting/postprandial, randomized, open-label, two-dose, four-period, fully repeated crossover bioequivalence study of sacubitril/valsartan sodium tablets in healthy volunteers
主要目的:通过空腹/餐后试验研究,考察中国健康受试者在空腹/餐后条件下单剂量口服石家庄市华新药业有限责任公司生产的沙库巴曲缬沙坦钠片(规格:200mg(沙库巴曲97mg/缬沙坦103mg))与Novartis Pharma Schweiz AG的沙库巴曲缬沙坦钠片(规格:200mg(沙库巴曲97mg/缬沙坦103mg))后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服沙库巴曲缬沙坦钠片(规格:200mg(沙库巴曲97mg/缬沙坦103mg))受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of sacubitril-valsartan sodium tablets (specification: 200 mg (sacubitril 97 mg/valsartan 103 mg)) produced by Shijiazhuang Huaxin Pharmaceutical Co., Ltd. and sacubitril-valsartan sodium tablets (specification: 200 mg (sacubitril 97 mg/valsartan 103 mg)) produced by Novartis Pharma Schweiz AG in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of a single oral dose of sacubitril-valsartan sodium tablets (specification: 200 mg (sacubitril 97 mg/valsartan 103 mg)) and reference preparations in healthy Chinese subjects.
100 Clinical Results associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.
100 Deals associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shijiazhuang Huaxin Pharmaceutical Co., Ltd.