[Translation] Study on the human bioequivalence of sildenafil citrate orally disintegrating tablets
本试验旨在研究健康受试者单次空腹口服北京星昊盈盛药业有限公司研制、生产的枸橼酸西地那非口崩片(50 mg)的药代动力学特征;以Upjohn EESV持证、Fareva Amboise生产的枸橼酸西地那非口崩片(万艾可®,50 mg)为参比制剂,比较两制剂中的药动学参数,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] This trial aims to study the pharmacokinetic characteristics of sildenafil citrate orally disintegrating tablets (50 mg) developed and produced by Beijing Xinghao Yingsheng Pharmaceutical Co., Ltd. in healthy subjects after a single fasting oral administration; Upjohn EESV Sildenafil citrate orally disintegrating tablets (Viagra®, 50 mg) produced by Fareva Amboise with a license are used as reference preparations. The pharmacokinetic parameters of the two preparations are compared, and the human bioequivalence of the two preparations is evaluated. Observe the safety of the two preparations in healthy subjects.
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