[Translation] A single oral, single-center, randomized, double-blind, placebo-controlled clinical study to evaluate the effect of TPN729MA tablets on the QT/QTc interval in healthy participants
主要目的:
1) 评价TPN729MA片单次口服给药后对中国健康参与者QT/QTc间期的影响。
次要目的:
1) 给药前后心电图参数(HR、PR、QRS间期)的变化。
2) 给药后出现T波形态异常和出现U波的参与者例数。
3) 给药后出现心律失常的参与者例数。
4) 评价TPN729MA片给药后在健康参与者中的药代动力学(PK)特征。
5) 评价TPN729MA片给药后在健康参与者中的安全性和耐受性。
[Translation] Primary objectives:
1) To evaluate the effect of a single oral administration of TPN729MA tablets on the QT/QTc interval in healthy Chinese participants.
Secondary objectives:
1) Changes in electrocardiographic parameters (HR, PR, QRS interval) before and after administration.
2) The number of participants with abnormal T wave morphology and U waves after administration.
3) The number of participants with arrhythmias after administration.
4) To evaluate the pharmacokinetic (PK) characteristics of TPN729MA tablets in healthy participants after administration.
5) To evaluate the safety and tolerability of TPN729MA tablets in healthy participants after administration.