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非諾貝特膠囊人體生物等效性研究

發(fā)布時(shí)間：

2023-07-12

適應癥：

供成人使用用于治療成人飲食控制療法效果不理想的高膽固醇血癥（Ⅱa 型），內源性高甘油三酯血癥，單純型（Ⅳ型）和混合型（IIb 和Ⅲ型）。特別是飲食控制后血中膽固醇仍持續升高，或是有其他并發(fā)的危險因素時(shí) 。在服藥過(guò)程中應繼續控制飲食。目前，尚無(wú)長(cháng)期臨床對照研究證明非諾貝特在動(dòng)脈粥樣硬化并發(fā)癥一級和二級預防方面的有效性。尚未證明非諾貝特能夠降低 2 型糖尿病患者的冠心病發(fā)病率和死亡。

試驗分組：

終點(diǎn)指標：

受試者人數：

序號	企業(yè)	受試者人數
1	安徽省先鋒制藥有限公司	84例
2	辰欣藥業(yè)股份有限公司	58例
3	江蘇必易生物科技有限公司	80例

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非諾貝特膠囊人體生物等效性研究

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