[Translation] Bioequivalence study of sildenafil citrate orodispersible film
主要目的:健康受试者在空腹或餐后状态下,以ヴィアトリス製薬株式会社持有的枸橼酸西地那非口溶膜(商品名:VIAGRA®;规格:50mg)为参比制剂,研究浙江乐普制药有限公司生产的枸橼酸西地那非口溶膜(规格:50mg)的吸收速度与吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: Healthy subjects were tested on an empty stomach or after a meal, using Sildenafil Citrate Orally Dissolvable Film (Trade Name: VIAGRA®; Specification: 50 mg) held by Biotech Co., Ltd. as a reference preparation. Study the absorption speed and degree of sildenafil citrate orally soluble film (specification: 50mg) produced by Zhejiang Lepu Pharmaceutical Co., Ltd., and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To observe the safety of oral administration of the test preparation and reference preparation to healthy subjects.
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