Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
brief summary
To assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization (QTc interval of the electrocardiogram, and to evaluate the safety and tolerability of a single IV bolus of HSK3486 in healthy subjects
detailed description
This is a single-center, randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive controlled study with a 6-sequence, three-period crossover design in healthy subjects. A blinded design is used for administration of HSK3486 and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.
Subjects meet the including criteria and none of exclusion criteria are randomized in equal proportion to one of 6 dosing sequences (see Table 2 for dosing sequences), and the study procedure consisted of 3 periods, with washout period of 5 days between periods.
Subjects are closely monitored on vital sign checking, 12-lead ECG, and Holter collection through out each treatment period.
official title
A Randomized, Positive and Placebo-Controlled Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects