枸櫞酸西地那非片主要用于治療男性勃起功能障礙，并適用于治療成人肺動脈高壓，屬臨床常用藥物。結(jié)合美國、中國該品種生物等效性試驗指導原則要求，通過對近年來中國開展的枸櫞酸西地那非片生物等效性試驗結(jié)果進行總結(jié)、分析，并對生物等效性試驗審評中發(fā)現(xiàn)的多種情況提出一般考慮。枸櫞酸西地那非片一般選擇40例男性健康受試者開展空腹及餐后生物等效性試驗，口崩片則建議僅開展空腹生物等效性試驗；建議關注生物等效性試驗中受試制劑與參比制劑達峰時間（t_max）的非參數(shù)檢驗結(jié)果。

Sildenafil Citrate Tablet is used for the treatment of male erectile dysfunction and pulmonary arterial hypertension, which is a common drug in clinic. Combining with the United States and China bioequivalence test guidelines requires, summary and analysis based on recent years bioequivalence result of Sildenafil Citrate Tablet in China, and propose general consideration on bioequivalence results of review. For Sildenafil Citrate Tablet bioequivalence research and development provide scientific basis and reference. About 40 healthy male subjects of Sildenafil Citrate Tablets were selected for fasting and fed bioequivalence tests, while only fasting bioequivalence was recommended for orally disintegrating tablets. At the same time, it was recommended to pay attention to the non-parametric test results of t_max between the test and reference in the bioequivalence test.

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