/ Active, not recruitingPhase 1 NF2105胶囊(150 mg空腹给药)及尼洛替尼胶囊(400 mg低脂改良空腹给药)在健康受试者中的药代动力学比对研究
[Translation] A comparative pharmacokinetic study of NF2105 capsules (150 mg, administered on an empty stomach) and nilotinib capsules (400 mg, administered on a low-fat modified empty stomach) in healthy subjects.
(1)评价并比较健康受试者单次口服NF2105胶囊(空腹)与尼洛替尼胶囊(低脂改良空腹)的药代动力学特征;(2)评价健康受试者单次口服NF2105胶囊(空腹)与尼洛替尼胶囊(低脂改良空腹)的相对生物利用度;(3)评估健康受试者单次口服NF2105胶囊(空腹)及尼洛替尼胶囊(低脂改良空腹)的安全性。
[Translation] (1) Evaluate and compare the pharmacokinetic characteristics of a single oral dose of NF2105 capsules (fasting) and nilotinib capsules (low-fat modified fasting) in healthy subjects; (2) Evaluate the relative bioavailability of a single oral dose of NF2105 capsules (fasting) and nilotinib capsules (low-fat modified fasting) in healthy subjects; (3) Assess the safety of a single oral dose of NF2105 capsules (fasting) and nilotinib capsules (low-fat modified fasting) in healthy subjects.
NF2105胶囊(112.5 mg)及尼洛替尼胶囊(300 mg)在健康受试者中的相对生物利用度研究
[Translation] Relative bioavailability study of NF2105 capsules (112.5 mg) and nilotinib capsules (300 mg) in healthy subjects.
(1)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;(2)评价健康受试者单次空腹口服NF2105胶囊与尼洛替尼胶囊的药代动力学特征;(3)评估健康受试者单次空腹口服NF2105胶囊及尼洛替尼胶囊的安全性。
[Translation] (1) To evaluate the relative bioavailability of NF2105 capsules and nilotinib capsules in healthy subjects after a single fasting oral administration; (2) To evaluate the pharmacokinetic characteristics of NF2105 capsules and nilotinib capsules in healthy subjects after a single fasting oral administration; (3) To assess the safety of NF2105 capsules and nilotinib capsules in healthy subjects after a single fasting oral administration.
NF2105胶囊及尼洛替尼胶囊在健康受试者中的药代动力学对比研究
[Translation] Comparative pharmacokinetic study of NF2105 capsules and nilotinib capsules in healthy subjects
(1)评价并比较健康受试者单次口服NF2105胶囊(空腹/餐后)、尼洛替尼胶囊(空腹/改良空腹)的药代动力学特征;(2)评价高脂饮食对健康受试者单次口服NF2105胶囊及尼洛替尼胶囊(改良空腹)药代动力学的影响;(3)评价健康受试者单次空腹口服NF2105胶囊与尼洛替尼原研胶囊的相对生物利用度;(4)评估健康受试者单次口服NF2105胶囊(空腹/餐后)及尼洛替尼胶囊(空腹/改良空腹)的安全性。
[Translation] (1) Evaluate and compare the pharmacokinetic characteristics of single oral administration of NF2105 capsules (fasting/postprandial) and nilotinib capsules (fasting/modified fasting) in healthy subjects; (2) Evaluate the effect of a high-fat diet on the pharmacokinetics of single oral administration of NF2105 capsules and nilotinib capsules (modified fasting) in healthy subjects; (3) Evaluate the relative bioavailability of single oral administration of NF2105 capsules and the original nilotinib capsules in healthy subjects (fasting/postprandial); (4) Assess the safety of single oral administration of NF2105 capsules (fasting/postprandial) and nilotinib capsules (fasting/modified fasting) in healthy subjects.
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