Shenzhen Taili Biomedicine Co., Ltd.

(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.

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.

The main purpose of the study: According to the relevant provisions of the bioequivalence test, the leprocaine cream (trade name: EMLA, specification: 1g: lidocaine 25mg, prilocaine 25mg) produced by Recipharm Karlskoga AB was selected as the reference preparation, and the test preparation leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) provided by Shenzhen Taili Biopharmaceutical Co., Ltd. was used for the human bioequivalence test of fasting administration. The absorption rate and degree of the drug in the test preparation were compared with the reference preparation to see whether they were within the acceptable range, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. The secondary purpose of the study: To observe the safety of Chinese healthy subjects after external use of the test preparation leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) and the reference preparation leprocaine cream (trade name: EMLA, specification: 1g: lidocaine 25mg, prilocaine 25mg).