[Translation] A single-center, randomized, open-label, two-cycle, self-crossover, single-dose design with fasting and postprandial administration to evaluate the human bioequivalence of calcium dobesilate capsules
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, double-cycle, self-crossover, single-dose administration design was used to compare the calcium dobesilate capsules (specification: 0.5 g) produced by Guizhou Tianan Pharmaceutical Co., Ltd. under the conditions of fasting and postprandial administration. Differences in the degree of absorption and absorption rate of calcium dobesilate capsules (trade name: Doxium®/Daoshengming®, specification: 0.5 g) with the licensee of Ebewe Pharma Ges.m.b.H.Nfg.KG in healthy Chinese population, And evaluate the safety of calcium dobesilate capsules produced by Guizhou Tianan Pharmaceutical Co., Ltd.