[Translation] An open, parallel-controlled, adaptive-designed pharmacokinetic and safety clinical study of Keprasen hydrochloride tablets in subjects with moderate renal impairment, severe renal impairment, and normal renal function
主要目的:
评估盐酸凯普拉生片在中度肾功能不全、重度肾功能不全和肾功能正常受试者中的药代动力学特征,为肾功能不全患者的合理临床用药提供科学依据。
次要目的:
评估盐酸凯普拉生片在中度肾功能不全、重度肾功能不全和肾功能正常受试者中的安全性和耐受性。
[Translation] Primary objective:
To evaluate the pharmacokinetic characteristics of Kepashen Hydrochloride Tablets in subjects with moderate renal insufficiency, severe renal insufficiency and normal renal function, and to provide a scientific basis for the rational clinical medication of patients with renal insufficiency.
Secondary objective:
To evaluate the safety and tolerability of Kepashen Hydrochloride Tablets in subjects with moderate renal insufficiency, severe renal insufficiency and normal renal function.