[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose design to evaluate the bioequivalence of calcium dobesilate capsules in humans with fasting and fed administration
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后给药条件下,贵州天安药业股份有限公司生产的羟苯磺酸钙胶囊(规格:0.5 g)与持证商为Ebewe Pharma Ges.m.b.H.Nfg.KG的羟苯磺酸钙胶囊(商品名:Doxium®/导升明®,规格:0.5 g)在中国健康人群中吸收程度和吸收速度的差异,并评价贵州天安药业股份有限公司生产的羟苯磺酸钙胶囊的安全性。
[Translation] A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and rate between calcium dobesilate capsules (specification: 0.5 g) produced by Guizhou Tianan Pharmaceutical Co., Ltd. and calcium dobesilate capsules (trade name: Doxium®/Doxium®, specification: 0.5 g) produced by Ebewe Pharma Ges.m.b.H.Nfg.KG in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of calcium dobesilate capsules produced by Guizhou Tianan Pharmaceutical Co., Ltd.