[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.