/ CompletedNot Applicable 中国男性健康受试者空腹和餐后单次口服盐酸达泊西汀片的随机、开放、单剂量、两制剂、两周期、两序列交叉设计的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy Chinese male volunteers after single oral administration on an empty stomach or after a meal
主要目的:研究单次空腹和餐后口服苏州海景医药科技有限公司研制、山东威智百科药业有限公司生产的盐酸达泊西汀片(60 mg)的药代动力学特征;以Berlin-Chemie AG持证、Menarini-Von Heyden GmbH生产的盐酸达泊西汀片(Priligy ®,60 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] Main objective: To study the pharmacokinetic characteristics of dapoxetine hydrochloride tablets (60 mg) developed by Suzhou Seaview Pharmaceutical Technology Co., Ltd. and produced by Shandong Weizhi Baike Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using dapoxetine hydrochloride tablets (Priligy ®, 60 mg) certified by Berlin-Chemie AG and produced by Menarini-Von Heyden GmbH as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
100 Clinical Results associated with Suzhou HIGEN Pharmaceutical Technology Co., Ltd
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100 Translational Medicine associated with Suzhou HIGEN Pharmaceutical Technology Co., Ltd