/ RecruitingNot Applicable 乙酰半胱氨酸颗粒在中国健康受试者中空腹/餐后单次口服、随机、开放、两制剂、两周期、两序列交叉生物等效性研究
[Translation] A single oral fasting/postprandial, randomized, open-label, two-formulation, two-period, two-sequence crossover bioequivalence study of acetylcysteine granules in healthy Chinese subjects
主要目的:通过健康受试者分别单次口服安徽华尔康药业有限公司持有的由上海华源安徽仁济制药有限公司生产的乙酰半胱氨酸颗粒(规格: 0.2g)与海南赞邦制药有限公司持证并生产的乙酰半胱氨酸颗粒(商品名:富露施®),对二者在健康受试者体内的生物利用度进行比较,评价两制剂的人体生物等效性。
次要目的:评价上海华源安徽仁济制药有限公司生产的乙酰半胱氨酸颗粒(规格:0.2g)的安全性。
[Translation] Primary objective: To compare the bioavailability of acetylcysteine granules (specification: 0.2g) produced by Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd. and licensed by Anhui Huaerkang Pharmaceutical Co., Ltd. and acetylcysteine granules (trade name: Fulushi®) produced by Hainan Zanbang Pharmaceutical Co., Ltd. in healthy subjects by taking them orally once, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of acetylcysteine granules (specification: 0.2g) produced by Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd.
/ CompletedNot Applicable 羟苯磺酸钙胶囊在健康受试者中空腹/餐后、单次口服、随机、开放、两制剂、两周期、交叉生物等效性研究
[Translation] A fasting/fed, single oral, randomized, open-label, two-dose, two-period, crossover bioequivalence study of calcium dobesilate capsules in healthy subjects
主要目的:通过对羟苯磺酸钙胶囊空腹和餐后口服给药的生物等效性研究,评价安徽华尔康药业有限公司持有的,上海华源安徽仁济制药有限公司生产的羟苯磺酸钙胶囊(规格:0.5g)与Klocke Pharma Service生产的羟苯磺酸钙胶囊(规格:0.5g)的生物等效性;为安徽华尔康药业有限公司持有的,上海华源安徽仁济制药有限公司生产的羟苯磺酸钙胶囊与Klocke Pharma Service生产的羟苯磺酸钙胶囊临床疗效的一致性提供证据。
次要目的:评价羟苯磺酸钙胶囊的临床安全性。
[Translation] Primary objective: To evaluate the bioequivalence of calcium dobesilate capsules (specification: 0.5g) produced by Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd. and Klocke Pharma Service through a bioequivalence study of fasting and postprandial oral administration of calcium dobesilate capsules; to provide evidence for the consistency of clinical efficacy of calcium dobesilate capsules produced by Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd. and Klocke Pharma Service.
Secondary objective: To evaluate the clinical safety of calcium dobesilate capsules.
100 Clinical Results associated with Anhui Huaerkang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Anhui Huaerkang Pharmaceutical Co., Ltd.
100 Deals associated with Anhui Huaerkang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Anhui Huaerkang Pharmaceutical Co., Ltd.