阿立哌唑片主要用于精神分裂癥的治療，屬精神類疾病臨床常用藥物。結(jié)合美國、中國該品種生物等效性試驗(yàn)指導(dǎo)原則要求，通過近年來在中國對(duì)阿立哌唑片開展的生物等效性試驗(yàn)結(jié)果進(jìn)行總結(jié)、分析，并對(duì)本品種生物等效性試驗(yàn)提出審評(píng)的一般要求如下：一般選擇36例45歲以上健康受試者開展空腹及餐后生物等效性試驗(yàn)；出于安全原因采用10 mg規(guī)格開展相關(guān)研究，并應(yīng)做好受試者試驗(yàn)期間的健康監(jiān)護(hù)；藥動(dòng)學(xué)參數(shù)方面，可使用截?cái)嘀?2 h的藥時(shí)曲線下面積（AUC）代替AUC_0～t或AUC_0～inf進(jìn)行生物等效性的統(tǒng)計(jì)分析，2周期間應(yīng)有足夠長的清洗期；對(duì)于阿立哌唑口崩片除上述要求外，服藥方式建議放置在舌頭上使其崩解后無水吞服。

Aripiprazole tablet is used for the treatment of schizophrenia, which is a common drug for psychiatric diseases in clinic. Combined with the United States and China Aripiprazole Tablet bioequivalence test guidelines requires, summary and analysis based on recent years bioequivalence result in China, and propose general review requirements for Aripiprazole Tablet bioequivalence test. Generally, about 36 healthy subjects over 45 years of age should be selected for fasting and fed bioequivalence of Aripiprazole Tablets. For safety reasons, 10mg was used to carry out related studies, and health monitoring of subjects should be done during the bioequivalence. In terms of pharmacokinetic parameters, AUC truncated to 72 hours can be used instead of AUC_0～t or AUC_0～inf for statistical analysis of bioequivalence, and there should be sufficient long cleaning period during the two-week period. In addition to the above requirements, for aripiprazole orally disintegrating tablets should be administered without water.