[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetics, and effects of food on pharmacokinetics of HSK45019 tablets in healthy subjects.
主要目的:评价HSK45019片在健康受试者中单次和多次给药的安全性和耐受性;
次要目的:
1. 评价HSK45019片在健康受试者中单次和多次给药后的药代动力学(PK)特征;
2. 评价食物对HSK45019片单次给药后药代动力学的影响;
探索性目的:
1. 探索HSK45019片在健康受试者中单次和多次给药后的药效动学(PD)特征;
2. 初步评估HSK45019片对QT间期的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of HSK45019 tablets after single and multiple administrations in healthy subjects;
Secondary Objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of HSK45019 tablets after single and multiple administrations in healthy subjects;
2. To evaluate the effect of food on the pharmacokinetics of HSK45019 tablets after a single administration;
Exploratory Objectives:
1. To explore the pharmacodynamic (PD) characteristics of HSK45019 tablets after single and multiple administrations in healthy subjects;
2. To preliminarily assess the effect of HSK45019 tablets on the QT interval.