[Translation] A single oral, randomized, double-blind, placebo-controlled safety, tolerability, and pharmacokinetics study of TPN102 tablets in healthy Chinese subjects
观察健康人单次给予TPN102片后的耐受性、安全性,评估TPN102片在健康人单次给药的安全剂量范围,及其在中国健康人体内的药代动力学特征,为制定多次给药的耐受性和药代动力学研究,以及II期临床试验给药方案提供依据;探索健康受试者口服TPN102片后的代谢产物及受试者基因组学信息与药物的药代动力学及安全性、耐受性的相关性。
[Translation] To observe the tolerance and safety of TPN102 tablets after a single administration in healthy subjects, evaluate the safe dosage range of TPN102 tablets in healthy subjects after a single administration, and its pharmacokinetic characteristics in healthy Chinese subjects, to provide a basis for the formulation of tolerance and pharmacokinetic studies of multiple administrations, as well as the dosing regimen for Phase II clinical trials; to explore the correlation between the metabolites of TPN102 tablets after oral administration in healthy subjects and the genomic information of the subjects and the pharmacokinetics, safety and tolerability of the drug.