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普洛藥業(000739.SZ):注射用索法地爾Ⅲ期臨牀試驗獲得倫理批准
格隆匯 10-14 21:08

格隆匯 10 月 14日丨普洛藥業(000739.SZ)公佈,近日,公司全資子公司浙江普洛家園藥業有限公司完成一項評價注射用索法地爾治療急性缺血性腦卒中的有效性、安全性的多中心、隨機、雙盲、安慰劑平行對照Ⅱ期臨牀研究;該研究目的是評價急性缺血性腦卒中受試者出現症狀8個小時內,注射用索法地爾低劑量、中劑量和高劑量給藥組對臨牀療效指標的影響。研究結果表明,在經靜脈溶栓治療的中重度急性缺血性患者中,與標準療法相比,索法地爾中/高劑量治療組有較好地促進患者神經功能恢復的趨勢;與其它治療組相比,高劑量組顯示出加快患者康復的趨勢;同時,安全性研究結果表明,索法地爾體現出良好的耐受性和安全性。

公司近期已完成與國家藥品監督管理局(NMPA)藥品審評中心(CDE)臨牀Ⅲ期啟動前溝通會,並獲得臨牀Ⅲ期研究組長單位首都醫科大學附屬北京天壇醫藥倫理委員會的同意批准。藥品名稱:注射用索法地爾;劑型:注射劑;規格:250mg/瓶;註冊分類:化學藥品第1類;申報階段:臨牀Ⅲ期研究。

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