[Translation] A human bioequivalence study of vardenafil hydrochloride orally disintegrating tablets in a single-center, randomized, open-label, single-dose, two-dose, two-cycle, two-sequence crossover design
本试验旨在研究单次餐后口服安徽四环科宝制药有限公司研制的盐酸伐地那非口崩片(10 mg)的药代动力学特征;以Alembic Pharmaceuticals Limited生产的盐酸伐地那非口崩片(10 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,并观察两制剂在健康男性受试者中的安全性。
[Translation] The purpose of this study is to study the pharmacokinetic characteristics of vardenafil hydrochloride orally disintegrating tablets (10 mg) produced by Anhui Sihuan Kebao Pharmaceutical Co., Ltd. after a single meal; vardenafil hydrochloride produced by Alembic Pharmaceuticals Limited Orally disintegrating tablet (10 mg) was used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of the two preparations were compared to evaluate the human bioequivalence of the two preparations. security.