[Translation] A single-dose, open-label, parallel-controlled phase I clinical trial to evaluate the pharmacokinetic characteristics and safety of TPN729MA tablets in male subjects with renal insufficiency and healthy subjects
主要目的:
评估单次给药后TPN729MA片原形及其代谢产物TPN-M3在不同程度肾功能不全及健康男性受试者中的药代动力学特征。
次要目的:
1)评估单次给药后TPN729MA片在不同程度肾功能不全及健康男性受试者中的安全性;
2)评估单次给药后TPN729MA片原形及其代谢产物TPN-M3在不同程度肾功能不全及健康男性受试中的血浆蛋白结合率。
[Translation] Primary objective:
To evaluate the pharmacokinetic characteristics of the original TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose.
Secondary objectives:
1) To evaluate the safety of TPN729MA tablets in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose;
2) To evaluate the plasma protein binding rate of the original TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose.