[Translation] A randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting and fed bioequivalence study of tamsulosin hydrochloride sustained-release capsules
浙江海力生制药有限公司生产的盐酸坦洛新缓释胶囊为受试制剂,安斯泰来制药(中国)有限公司生产的盐酸坦索罗辛缓释胶囊为参比制剂,比较盐酸坦洛新缓释胶囊在中国健康受试者体内的药代动力学行为,评价空腹及餐后口服两种制剂的生物等效性。评价空腹及餐后口服受试制剂和参比制剂后的安全性。
[Translation] The tamsulosin hydrochloride sustained-release capsules produced by Zhejiang Hailisheng Pharmaceutical Co., Ltd. were used as the test preparation, and the tamsulosin hydrochloride sustained-release capsules produced by Astellas Pharma (China) Co., Ltd. were used as the reference preparation. The pharmacokinetic behavior of tamsulosin hydrochloride sustained-release capsules in healthy Chinese subjects was compared, and the bioequivalence of the two preparations after oral administration on an empty stomach and after a meal was evaluated. The safety of the test preparation and the reference preparation after oral administration on an empty stomach and after a meal was evaluated.