公开(公告)号：US20110002989A1

公开(公告)日：2011-01-06

申请号：US12920400

申请日：2009-03-04

申请人： William John Curatolo ,  Scott Max Herbig ,  Avinash Govind Thombre ,  Jaymin Chandrakant Shah ,  Sheri L. Shamblin ,  Timothy Lukas ,  William Brett Caldwell ,  Dwayne Thomas Friesen ,  David Keith Lyon ,  Christopher Donovan Craig

发明人： William John Curatolo ,  Scott Max Herbig ,  Avinash Govind Thombre ,  Jaymin Chandrakant Shah ,  Sheri L. Shamblin ,  Timothy Lukas ,  William Brett Caldwell ,  Dwayne Thomas Friesen ,  David Keith Lyon ,  Christopher Donovan Craig

IPC分类号： A61K31/496 ,  A61P25/00 ,  A61K31/724 ,  A61K31/717 ,  A61K9/22

CPC分类号： A61K31/496

摘要： The present invention provides methods, dosage forms and kits for treating with an effective amount of ziprasidone a CNS disorder in a human when the human is in a fasted state. In one embodiment, the invention relates to a method for treating a CNS disorder in a human, which method comprises administering to the human in a fasted state, a solid oral dosage form comprising an amount of ziprasidone effective to treat said CNS disorder, wherein the area under the serum concentration versus time curve (AUC0-inf) of the ziprasidone in the human subsequent to said administering is from 70% to 140% of the mean area under the ziprasidone serum concentration versus time curve (AUC0-inf) resulting from administration of a control ziprasidone immediate release oral capsule containing the same amount of ziprasidone to a cohort of humans in a fed state.

摘要翻译： 本发明提供了当人处于禁食状态时用人体中有效量的齐拉西酮治疗CNS病症的方法，剂型和试剂盒。 在一个实施方案中，本发明涉及一种用于治疗人类中枢神经系统疾病的方法，所述方法包括以禁食状态对人施用包含有效治疗所述CNS病症的量的齐拉西酮的固体口服剂型，其中 在所述给药之后，人体中齐拉西酮的血清浓度对时间曲线（AUC 0-inf）下的面积是由给药引起的齐拉西酮血清浓度对时间曲线（AUC 0-inf）的平均面积的70％至140％ 的控释齐拉昔酮立即释放口服胶囊含有相同数量的齐拉西酮至饲喂状态的人群。