統合失調症または統合失調症の患者における長効パリペリドンの多中心生物学的利用可能性研究
Thalita Martins da Silva1, Débora Renz Barreto Vianna2, Jessica Meulman1
1Department of Operations, Clinical Research Unit, Adium S.A., São Paulo, São Paulo,Brazil.
Journal of clinical psychopharmacology
|September 3, 2025
まとめ
ベガパリドンパルミテートという新しい長作用注射剤は,基準薬と同等である. これは統合失調症の治療における有効性と安全性を確認し,患者のLAI抗精神病薬へのアクセスを改善しました.
科学分野:
- 薬理学と医薬品科学
- 精神科 と 精神 保健
- 臨床研究
背景:
- 統合失調症の治療 経口抗精神病薬への不服従は再発と医療費の増加につながります
- パリペリドン・パルミテートのような長時間作用の注射抗精神病薬は,再発のリスクを軽減します.
- LAI抗精神病薬の生物同等の配合は,安全性と有効性を維持しながら治療のアクセシビリティを改善します.
研究 の 目的:
- 試験用パリペリドンパルミテート延長放出注射サスペンション (PP-ERIS) の生物等価性を評価する.
- 統合失調症や統合失調症の患者でVegapaliを基準製剤であるInvega Sustennaと比較する.
主な方法:
- 7ヶ月間,多センター,ランダム化,オープンラベル,パラレルアームの薬理学 (PK) 研究.
- テスト薬 (Vegapali) または基準薬の月間注射
- 安定状態のPKパラメータ (Cmax,ss,AUCτ,ss) を決定した. ジオメトリック平均比率の90%CIが80. 00% - 125. 00%であった場合,バイオエキワレンスは確認された.
主要な成果:
- 薬理学分析により,Cmax,ss とAUCτ,ss の90%のCIが 80. 00% - 125. 00%の範囲で確認された.
- 両方とも比較可能な全身暴露を示した.
- パリペリドンパルミタートの既知の安全性プロファイルと一致した.
結論:
- 試験用成分であるVegapaliは,基準のパリペリドンパルミタートLAIに生物同等である.
- ベガパリは統合失調症の有効な代替LAI治療法であり,治療効果の同等性を保証しています.
- この発見により 統合失調症の効果的で持続的な治療法へのアクセスが 拡大しています
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