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Clinical Trials associated with NF2105高脂饮食对健康受试者口服NF2105胶囊的药代动力学以及QT/QTc间期影响的对比研究
[Translation] Comparative study on the effects of high-fat diet on the pharmacokinetics and QT/QTc interval of oral NF2105 capsules in healthy subjects
(1)评价高脂饮食对健康受试者单次口服NF2105胶囊的药代动力学影响;
(2)评价NF2105胶囊(餐前/餐后)及尼洛替尼(400mg)胶囊空腹给药后对中国健康受试者QT/QTc间期的影响;
(3)初步评价健康受试者单次空腹口服NF2105胶囊与尼洛替尼胶囊的相对生物利用度;
(4)评价健康受试者单次口服NF2105胶囊(空腹或餐后)及尼洛替尼胶囊(空腹)的PK特征以及PK/PD(QT/QTc间期)的特性;
(5)评价健康受试者口服NF2105胶囊或尼洛替尼胶囊的安全性。
[Translation] (1) To evaluate the effect of a high-fat diet on the pharmacokinetic response of a single oral administration of NF2105 capsules to healthy subjects;
(2) To evaluate the effect of NF2105 capsules (before or after meals) and nilotinib (400 mg) capsules on the QT/QTc interval after fasting administration to healthy Chinese subjects;
(3) To preliminarily evaluate the relative bioavailability of NF2105 capsules and nilotinib capsules after a single oral administration to healthy subjects on an empty stomach;
(4) To evaluate the PK characteristics and PK/PD (QT/QTc interval) of a single oral administration of NF2105 capsules (fasting or after meals) and nilotinib capsules (fasting) to healthy subjects;
(5) To evaluate the safety of oral administration of NF2105 capsules or nilotinib capsules to healthy subjects.
NF2105胶囊及尼洛替尼胶囊在健康受试者的剂量比例关系研究
[Translation] Study on the dose ratio relationship between NF2105 capsules and nilotinib capsules in healthy subjects
主要目的:考察健康受试者单次空腹口服不同剂量NF2105的PK特征及剂量比例关系;比较健康受试者单次空腹口服NF2105及尼洛替尼胶囊的PK特征,探索两者具有相似暴露水平的剂量。次要目的:评价健康受试者单次空腹口服不同剂量NF2105的安全性和耐受性;评价NF2105及尼洛替尼胶囊对健康受试者QT/QTc间期的影响。
[Translation] Primary objective: To investigate the PK characteristics and dose-proportion relationship of NF2105 in healthy subjects after single oral administration of different doses on an empty stomach; To compare the PK characteristics of NF2105 and nilotinib capsules in healthy subjects after single oral administration on an empty stomach, and to explore the doses with similar exposure levels. Secondary objective: To evaluate the safety and tolerability of NF2105 in healthy subjects after single oral administration of different doses on an empty stomach; To evaluate the effects of NF2105 and nilotinib capsules on the QT/QTc interval in healthy subjects.
100 Clinical Results associated with NF2105
100 Translational Medicine associated with NF2105
100 Patents (Medical) associated with NF2105
100 Deals associated with NF2105