[Translation] A single-center, open, randomized, two-dose, two-sequence, two-period, double-crossover human bioequivalence study of a single oral administration of calcium dobesilate capsules in Chinese healthy subjects under fasting and postprandial states
研究健康受试者空腹及餐后单次口服受试制剂羟苯磺酸钙胶囊(海南斯达制药有限公司,规格:0.5g)与参比制剂羟苯磺酸钙胶囊(商品名:Doxium ®,规格:0.5g)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后条件下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Study healthy volunteers on an empty stomach and after a single oral administration of the test preparation calcium dobesilate capsules (Hainan Star Pharmaceutical Co., Ltd., specification: 0.5g) and the reference preparation calcium dobesilate capsules (trade name: Doxium ® , specification: 0.5g) whether there are differences in the degree and speed of absorption, evaluate the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions, observe the test preparation and the reference preparation in healthy Safety in subjects.