[Translation] A randomized, open-label, two-dose, oral single-dose, two-cycle, two-crossover fasting and postprandial bioequivalence trial 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] Tamsulosin Hydrochloride Sustained-Release Capsules produced by Zhejiang Hailisheng Pharmaceutical Co., Ltd. were the test preparations, and Tamsulosin Hydrochloride Sustained-Release Capsules produced by Astellas Pharmaceuticals (China) Co., Ltd. were the reference preparations. Pharmacokinetic behavior of the new sustained-release capsules in healthy Chinese subjects, evaluating the bioequivalence of two formulations administered orally on an empty stomach and after meals. The safety of the test preparation and the reference preparation was evaluated on an empty stomach and after meals.