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李氏大藥廠(00950.HK)成功招募首名病人在III期臨牀試驗中使用Cetraxal®Plus
格隆匯 01-13 20:21

格隆匯 1 月 13日丨李氏大藥廠(00950.HK)公吿,於2021年1月4日,公司全資附屬公司兆科藥業(合肥)有限公司於中國成功招募首名病人在III期臨牀試驗中使用Cetraxal®Plus。Cetraxal®Plus為Laboratorios Salvat,S.A.("Salvat")特許授權的滴耳液產品,治療急性外耳道炎及伴有鼓膜置管的急性中耳炎。

此試驗的設計為由復旦大學附屬眼耳鼻喉科醫院的袁雅生醫生擔任首席研究者於44個臨牀中心進行。此為一項多中心、隨機、評估者盲性、並行組別、主動控制的III期臨牀試驗,旨在評估環丙沙星0.3%加醋酸氟輕鬆0.025%(CIPRO+FLUO)耳液對治療急性外耳道炎的療效及安全性。此臨牀試驗的設計為招募合共600名對象(300名屬Cetraxal®Plus組別,300名屬陽性對照藥組別)。此試驗的首要評估指標為將CIPRO+FLUO耳液對治療急性外耳道炎的療效,與環丙沙星0.3%耳液的療效比對。關鍵次要評估指標為將CIPRO+FLUO耳液對治療急性外耳道炎的安全性,與環丙沙星0.3%耳液的安全性比對,以及評估12名成人對象在多次使用CIPRO+FLUO耳液後,環丙沙星及醋酸氟輕鬆的血漿濃度,同時評估藥代動力學參數。

Laboratorios Salvat S.A.為一間私有藥業集團,從事產品開發及製造,以技術創新及致力於研發馳名。Laboratorios Salvat S.A.於一九五五年創立,總部位於巴塞羅那(西班牙),旗下美國附屬公司Salvat USA則位於佛羅里達州邁阿密。Salvat現進駐超過60個國家,並一直通過特許授權其自家開發擴充其國際版圖。 

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