カリプラジンの2つのハードカプセル製剤の生物同等性評価
Mamdouh R Rezk1, Kamal A Badr2, Ahmed Abd El Hamid Hosny3
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Naunyn-Schmiedeberg's archives of pharmacology
|February 14, 2026
まとめ
新しいジェネリックカリプラジンカプセルVocarzineは,リファレンス製品Reagila®と生物対価性を実証しました. この発見は,Vocarzineを統合失調症と双極性障害の治療のための安全で潜在的にコスト削減可能な代替手段として支持しています.
科学分野:
- 薬理学と医薬品科学について
- 臨床薬局 臨床薬局について
- ドラッグ開発 ドラッグ開発
背景:
- カリプラジンは,統合失調症と双極性I型障害に対する第3世代の抗精神病薬です.
- アクセシブルで手頃な価格の製剤は,特にリソースが限られた環境では,患者の遵守に不可欠です.
研究 の 目的:
- ブランドレファレンス製品 (Reagila®) と比較して,新しいジェネリックカリプラジンハードカプセル (Vocarzine) の生物同等性,安全性,耐受性を評価する.
主な方法:
- ランダム化され,オープンラベル,単回投与,2期,2シーケンスのクロスオーバー研究で,30人の健康な成人の参加者が参加しました.
- CmaxとAUC0-72hを決定するために,検証されたLC-MS/MS方法を使用して,薬理学分析を行いました.
- ジオメトリック平均比率の90%信頼区間が80~125%の範囲内であった場合,生物学的同等性は確立された.
主要な成果:
- 29人の参加者が研究を完了しました.
- Cmax (91.92% [85.07-99.33%]) とAUC0-72h (92.85% [88.86-97.02%]) の幾何学平均比率 (90% CI) は,生物同等性範囲内にありました.
- 両方とも比較可能な安全性プロファイルを示し,軽度の吐き気が最も頻繁に発生する有害事象であり,深刻な有害事象は報告されていません.
結論:
- 一般的なVocarzineハードカプセルは,吸収率と範囲の観点から,ブランドのReagila®カリプラジンハードカプセルに生物対価です.
- Vocarzineは,カリプラジン療法に対する安全で効果的な,そして潜在的にコストを削減する代替案を提示します.
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