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Clinical Trials associated with QJ-19-0002QJ-19-0002片在中国健康受试者中的耐受性和药代动力学临床试验研究
[Translation] Clinical trial study on the tolerability and pharmacokinetics of QJ-19-0002 tablets in Chinese healthy subjects
评价食物对健康受试者单次口服QJ-19-0002片后药代动力学(PK)的影响
[Translation] To evaluate the effect of food on the pharmacokinetics (PK) of QJ-19-0002 after a single oral administration of QJ-19-0002 tablets in healthy subjects
QJ-19-0002片在中国健康受试者中的耐受性和药代动力学临床试验研究
[Translation] Clinical trial study on the tolerability and pharmacokinetics of QJ-19-0002 tablets in Chinese healthy subjects
主要目的:
1.评价健康受试者单次和多次的耐受性与安全性,确定最大耐受剂量,考察该药的不良反应特征;
2.评价健康受试者单次和多次的药代动力学(PK)特征,考察线性特征以及多次给药的蓄积性;
3.评价该药在健康受试者中的代谢与生物转化特征;
4.通过C-QTc分析评估该药的心脏毒性;
5.评价该药的药代动力学(PK)和药效动力学(PD)是否存在性别差异。
次要目的:
评价健康受试者单次和多次后的药效动力学(PD)特征。
[Translation] Main objectives:
1. Evaluate the tolerance and safety of single and multiple doses in healthy subjects, determine the maximum tolerated dose, and investigate the adverse reaction characteristics of the drug;
2. Evaluate the pharmacokinetic (PK) characteristics of single and multiple doses in healthy subjects, investigate the linear characteristics and accumulation of multiple doses;
3. Evaluate the metabolism and biotransformation characteristics of the drug in healthy subjects;
4. Evaluate the cardiotoxicity of the drug by C-QTc analysis;
5. Evaluate whether there are gender differences in the pharmacokinetics (PK) and pharmacodynamics (PD) of the drug.
Secondary objectives:
Evaluate the pharmacodynamic (PD) characteristics of healthy subjects after single and multiple doses.
100 Clinical Results associated with QJ-19-0002
100 Translational Medicine associated with QJ-19-0002
100 Patents (Medical) associated with QJ-19-0002
100 Deals associated with QJ-19-0002