[Translation] A single-center, randomized, double-blind, placebo-controlled study evaluating the effects of a single oral dose of 4 mg and 12 mg succinylcholine on QT interval prolongation in healthy adults
主要目的:评估中国成年健康志愿者单次口服琥珀八氢氨吖啶片4 mg及12 mg对QT间期延长的影响。 次要目的:评估单次口服琥珀八氢氨吖啶片4 mg及12 mg情况下,血药浓度与QTc间期变化的关系;药代动力学(PK)特征;受试者的耐受性;如有主要代谢产物将评价其对QT间期延长的影响。
[Translation] Primary objective: To evaluate the effect of a single oral administration of 4 mg and 12 mg of succinic acid tablets on QTc prolongation in healthy adult Chinese volunteers. Secondary objectives: To evaluate the relationship between blood drug concentration and QTc interval changes after a single oral administration of 4 mg and 12 mg of succinic acid tablets; pharmacokinetic (PK) characteristics; tolerability of subjects; if there are major metabolites, their effects on QTc prolongation will be evaluated.