佐力藥業(300181.SZ):聚卡波非鈣片獲得臨牀試驗默示許可
格隆匯5月6日丨佐力藥業(300181.SZ)公佈,近日,公司在國家藥品監督管理局藥品審評中心網站查詢,獲悉公司向國家藥品監督管理局提交的“聚卡波非鈣片”獲得臨牀試驗默示許可。
公司已取得國家藥品監督管理局核發的聚卡波非鈣片《藥品註冊證書》,本品用於緩解腸易激綜合徵(便祕型)患者的便祕症狀。
聚卡波非鈣在胃內酸性條件下脱鈣變成聚卡波非,聚卡波非在小腸或大腸的中性環境下具有高度的吸水性,膨脹成為凝膠,保持消化道內水分平衡,調節消化道內容物的輸送,從而改善便祕或腹瀉症狀,“聚卡波非鈣片”本次申請臨牀試驗是為了增加“腸易激綜合徵引起的腹瀉”適應症,以擴大該品的臨牀應用範圍和滿足患者需求。
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