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(dòng)脈高壓，屬臨床常用藥物。結(jié)合美國(guó)、中國(guó)該品種生物等效性試驗(yàn)指導(dǎo)原則要求，通過(guò)對(duì)近年來(lái)中國(guó)開(kāi)展的枸櫞酸西地那非片生物等效性試驗(yàn)結(jié)果進(jìn)行總結(jié)、分析，并對(duì)生物等效性試驗(yàn)審評(píng)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(kāi)展空腹及餐后生物等效性試驗(yàn)，口崩片則建議僅開(kāi)展空腹生物等效性試驗(yàn)；建議關(guān)注生物等效性試驗(yàn)中受試制劑與參比制劑達(dá)峰時(shí)間（t_max）的非參數(shù)檢驗(yàn)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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