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Clinical Trial Summary

This is a single-dose orally administered, dose-escalation, single-center, randomized, double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect of TPN171H tablets on QT/QTc interval in healthy Chinese subjects after a single oral administration.


Clinical Trial Description

This trial was a single-center, randomized, double-blind, placebo parallel controlled trial of TPN171H tablets with single oral administration, dose escalation, in healthy Chinese subjects. This trial plans to set up 4 dose groups, and a total of 32 healthy adult subjects are expected to be enrolled. All subjects will receive a single oral dose under fasting state, and complete 3 days of PK blood sampling, 12-lead ECG examination and other safety checks. The trial was sequential according to the principle of dose escalation, that is, the next dose group was tested on the premise that the safety and tolerability of the previous group were good. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05750355
Study type Interventional
Source Vigonvita Life Sciences
Contact
Status Completed
Phase Phase 1
Start date October 10, 2022
Completion date December 7, 2022

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