[Translation] Phase I clinical trial of safety, tolerability, pharmacokinetics and food effects of single and multiple doses of XZP-6019 tablets in healthy adults
主要目的:
1、评价XZP-6019片在健康成年人中单次、多次给药的安全性和耐受性
2、评价XZP-6019片在健康成年人中单次、多次给药的药代动力学特征
3、评价进食对健康成年人单次口服XZP-6019片的药代动力学影响
次要目的:
评价XZP-6019片在健康成年人中单次、多次给药的药效学特征
探索性目的:
1、探索XZP-6019片在人体的代谢产物特征
2、探索XZP-6019片的C-QTc规律(如必要)
评价果糖对健康成年人单次口服XZP-6019片的药代动力学影响
[Translation] Main purpose:
1. Evaluate the safety and tolerability of single and multiple administrations of XZP-6019 tablets in healthy adults
2. Evaluate the pharmacokinetic characteristics of single and multiple administrations of XZP-6019 tablets in healthy adults
3. Evaluate the effect of food on the pharmacokinetic characteristics of single oral administration of XZP-6019 tablets in healthy adults
Secondary purpose:
Evaluate the pharmacodynamic characteristics of single and multiple administrations of XZP-6019 tablets in healthy adults
Exploratory purpose:
1. Explore the characteristics of metabolites of XZP-6019 tablets in the human body
2. Explore the C-QTc law of XZP-6019 tablets (if necessary)
Evaluate the effect of fructose on the pharmacokinetics of single oral administration of XZP-6019 tablets in healthy adults