[Translation] A Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of TJ0113 capsules after single, multiple, and postprandial oral administration in healthy subjects
主要目的:评价TJ0113胶囊单次、多次、标准高脂饮食后,口服给药后的安全性和耐受性。
次要目的:评价TJ0113胶囊单次、多次、标准高脂饮食后,口服给药后的药代动力学特征;
探索性目的:探索TJ0113胶囊单次、多次、标准高脂饮食后,口服给药后的生物表征。
[Translation] Primary purpose: To evaluate the safety and tolerability of TJ0113 capsules after single, multiple, and standard high-fat diet oral administration.
Secondary purpose: To evaluate the pharmacokinetic characteristics of TJ0113 capsules after single, multiple, and standard high-fat diet oral administration;
Exploratory purpose: To explore the biological characterization of TJ0113 capsules after single, multiple, and standard high-fat diet oral administration.